Authorized Representative
🇩🇪 Germany
Johner Medical GmbH
SRN: DE-AR-000011832
·
Niddastr. 91, 60329 Frankfurt, Germany
Manufacturers
12
Devices
119
Certificates
3
PRRCs
2
Basic Information
- Address
- Niddastr. 91, 60329 Frankfurt, Germany
- [email protected]
- Website
- www.johner-medical.de
- VAT Number
- DE327365389
- Trade Register
- HRB721028
- EORI
- DE378951060137751
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Ningbo Troika Medical Products Company Limited | 🇨🇳 China | CN-MF-000014144 |
| NDD Medizintechnik AG | 🇨🇠Switzerland | CH-MF-000015550 |
| PEDeus AG | 🇨🇠Switzerland | CH-MF-000017885 |
| Aerolite AG | 🇨🇠Switzerland | CH-MF-000013572 |
| Medizintechnik Basler AG | 🇨🇠Switzerland | CH-MF-000018117 |
| Hamilton Company | 🇺🇸 United States | US-MF-000025480 |
| Hamilton Bonaduz AG | 🇨🇠Switzerland | CH-MF-000013585 |
| Mindways Software, Inc. | 🇺🇸 United States | US-MF-000012877 |
| Hawest Research AG | 🇨🇠Switzerland | CH-MF-000036880 |
| Health & Medical Service AG | 🇨🇠Switzerland | CH-MF-000044953 |
| ARTIDIS AG | 🇨🇠Switzerland | CH-MF-000034687 |
| Oncobit AG | 🇨🇠Switzerland | CH-MF-000037436 |
Manufacturers
Hamilton Company
Manufacturer
🇺🇸 United States·3 Importers
PEDeus AG
Manufacturer
🇨🇠Switzerland
Ningbo Troika Medical Products Company Limited
Manufacturer
🇨🇳 China
Hawest Research AG
Manufacturer
🇨🇠Switzerland
Health & Medical Service AG
Manufacturer
🇨🇠Switzerland
Medizintechnik Basler AG
Manufacturer
🇨🇠Switzerland·1 Importer
Aerolite AG
Manufacturer
🇨🇠Switzerland
NDD Medizintechnik AG
Manufacturer
🇨🇠Switzerland·3 Importers
Hamilton Bonaduz AG
Manufacturer
🇨🇠Switzerland·92 Basic UDI-DIs·92 Devices·7 Importers·TÃœV Rheinland LGA Products GmbH, TÃœV Rheinland LGA Products GmbH, and TÃœV Rheinland LGA Products GmbH
Mindways Software, Inc.
Manufacturer
🇺🇸 United States·1 Importer
Oncobit AG
Manufacturer
🇨🇠Switzerland·6 Basic UDI-DIs·27 Devices·1 Importer
ARTIDIS AG
Manufacturer
🇨🇠Switzerland
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| IVDR QMS | HX 1774385-1 | Hamilton Bonaduz AG | TÃœV Rheinland LGA Products GmbH | Issued |
| IVDD Annex IV (excluding sections 4, 6) | SX601393670001 | Hamilton Bonaduz AG | TÃœV Rheinland LGA Products GmbH | Expired |
| IVDD Annex IV (excluding sections 4, 6) | SX 60139367 0001 | Hamilton Bonaduz AG | TÃœV Rheinland LGA Products GmbH | Expired |
Devices
VeriPlate Base Kit with Flatbed Scanner
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
VeriPlate Set of 200 (10ql)
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
VeriPlate Set of 50 (10ql)
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
VeriPlate Set of 10 (10ql)
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
VeriPlate Set of 5 (10ql)
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
STAR CL
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
50 μL Tips, Conductive, Filter, ISCC PLUS BioCir
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
50 μL Tips, Conductive, ISCC PLUS BioCir
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market
IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·Not intended for eu market
IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market
IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market
CO-RE II Welcome EU
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Deep Well Plate PP 0.8ML BC
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Container
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market
Reagent Container
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Container
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Container
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
MassSTAR
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
ampliCube
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
AltoStar® Automation System AM16
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
ALTOSTAR CONNECT SW
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
SENTiNAT 200
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Microlab STARlet IVD-R
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Microlab STAR IVD-R
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
cobas x 480 instrument
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
RIDA®UNITY
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Clinical NGS STARlet UV
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Clinical NGS STARlet
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
GenoXtract fleXT
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Unio96
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, sterile
Device
EU IVDD
·
Eu Ivd General
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Containers
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Field Verification Kit
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Field Verification Kit
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Field Verification Kit
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Field Verification Kit
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Deep Well Plates
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Deep Well Plates
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Containers
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Containers
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Containers
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Containers
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Containers
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Containers
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Reservoirs
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Reagent Reservoirs
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE II Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
CO-RE Tips, black, non-sterile
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
ML STARlet IVD-R
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Microlab STAR IVD-R
Device
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·On the market·32 countries
Oncobit PM BRAF V600E PPM 200rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600D Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600R Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600D PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600R PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600K Control 50rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600K PPM 200rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600E2 Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600E2 PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM BRAF V600E Control 50rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM Analyzer
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM SF3B1R625H Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM SF3B1R625H PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM SF3B1R625C Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM SF3B1R625C PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM NRASQ61R Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM NRASQ61R PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM NRASQ61L Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM NRASQ61L PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM NRASQ61K Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM NRASQ61K PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM GNAQ209P Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM GNAQ209P PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM GNAQ209L Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM GNAQ209L PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM GNA11Q209L Control 10rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries
Oncobit PM GNA11Q209L PPM 40rxn
Device
EU IVDR
·
Eu Ivd Class C
·Oncobit AG·On the market·9 countries