Authorized Representative
๐ณ๐ฑ Netherlands
Active
WMDE B.V.
SRN: NL-AR-000002062
ยท
Bergerweg 18, 6085 AT Horn, Netherlands
Manufacturers
14
Devices
47
Certificates
3
PRRCs
1
Basic Information
- Address
- Bergerweg 18, 6085 AT Horn, Netherlands
- [email protected]
- Website
- www.wmde.nl
- VAT Number
- NL 8574.41.784.B01
- Trade Register
- 68436688
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| NeuroLogica Corp., a subsidiary of Samsung Electronics Co., Ltd. | ๐บ๐ธ United States | US-MF-000008704 |
| Silipos Holding LLC. | ๐บ๐ธ United States | US-MF-000015547 |
| Checkpoint Surgical, Inc. | ๐บ๐ธ United States | US-MF-000008429 |
| Kawamoto Corporation | ๐ฏ๐ต Japan | JP-MF-000017129 |
| Omega Surgical Instruments | ๐บ๐ธ United States | US-MF-000035268 |
| Massachusetts Eye and Ear Infirmary | ๐บ๐ธ United States | US-MF-000022771 |
| Cellabs Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000030640 |
| Qvella Corporation | ๐จ๐ฆ Canada | CA-MF-000026799 |
| Contract Sterilization Services Pte Ltd | ๐ธ๐ฌ Singapore | SG-MF-000029846 |
| Tekscan Inc. | ๐บ๐ธ United States | US-MF-000008716 |
| Inami & Co., Ltd. | ๐ฏ๐ต Japan | JP-MF-000040062 |
| Harald Nordin S.A. | ๐จ๐ญ Switzerland | CH-MF-000016069 |
| Advanced Instruments, LLC | ๐บ๐ธ United States | US-MF-000027205 |
| Qnostics Ltd. | ๐ฌ๐ง United Kingdom | UK-MF-000047352 |
Manufacturers
Contract Sterilization Services Pte Ltd
Manufacturer
๐ธ๐ฌ Singapore
Checkpoint Surgical, Inc.
Manufacturer
๐บ๐ธ United States·2 Basic UDI-DIs·2 Devices·6 Importers·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
Kawamoto Corporation
Manufacturer
๐ฏ๐ต Japan
NeuroLogica Corp., a subsidiary of Samsung Electronics Co., Ltd.
Manufacturer
๐บ๐ธ United States·3 Importers
Tekscan Inc.
Manufacturer
๐บ๐ธ United States
Inami & Co., Ltd.
Manufacturer
๐ฏ๐ต Japan·7 Basic UDI-DIs·10 Devices·5 Importers·TรV Rheinland LGA Products GmbH
Qvella Corporation
Manufacturer
๐จ๐ฆ Canada·1 Importer
Harald Nordin S.A.
Manufacturer
๐จ๐ญ Switzerland·2 Basic UDI-DIs·26 Devices·9 Importers
Qnostics Ltd.
ManufacturerMassachusetts Eye and Ear Infirmary
Manufacturer
๐บ๐ธ United States
Omega Surgical Instruments
Manufacturer
๐บ๐ธ United States
Cellabs Pty Ltd
Manufacturer
๐ฆ๐บ Australia·3 Importers
Silipos Holding LLC.
Manufacturer
๐บ๐ธ United States·4 Importers
Advanced Instruments, LLC
Manufacturer
๐บ๐ธ United States·2 Basic UDI-DIs·9 Devices·4 Importers
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 676122 | Checkpoint Surgical, Inc. | BSI Group The Netherlands B.V. | Expired |
| MDD Annex II (excluding section 4) | CE 676122 | Checkpoint Surgical, Inc. | BSI Group The Netherlands B.V. | Expired |
| MDD Annex V | DD60129973001 | Inami & Co., Ltd. | TรV Rheinland LGA Products GmbH | Expired |
Devices
Checkpoint Surgical Head & Neck Nerve Stimulator
Device
EU MDD
·
Eu Md Class 2a
·Checkpoint Surgical, Inc.·On the market·19 countries
Checkpoint Surgical Nerve Stimulator
Device
EU MDD
·
Eu Md Class 2a
·Checkpoint Surgical, Inc.·On the market·12 countries
Tanito Micro Hook (TMHยฎ)
Device
EU MDR
·
Eu Md Class 2a
·Inami & Co., Ltd.·On the market·7 countries
Tanito Micro Hook (TMHยฎ)
Device
EU MDR
·
Eu Md Class 2a
·Inami & Co., Ltd.·On the market·6 countries
Applanation Tonometer
Device
EU MDD
·
Eu Md Class 1
·Inami & Co., Ltd.·On the market·5 countries
Applanation Tonometer
Device
EU MDD
·
Eu Md Class 1
·Inami & Co., Ltd.·On the market·7 countries
Synoptiscope
Device
EU MDD
·
Eu Md Class 1
·Inami & Co., Ltd.·On the market·10 countries
Synoptiscope
Device
EU MDD
·
Eu Md Class 1
·Inami & Co., Ltd.·On the market·6 countries
UNIVERSAL TRIAL FRAME
Device
EU MDR
·
Eu Md Class 1
·Inami & Co., Ltd.·On the market·10 countries
TRIAL FRAME
Device
EU MDR
·
Eu Md Class 1
·Inami & Co., Ltd.·On the market·10 countries
TRIAL FRAME
Device
EU MDR
·
Eu Md Class 1
·Inami & Co., Ltd.·On the market·10 countries
TRIAL FRAME
Device
EU MDR
·
Eu Md Class 1
·Inami & Co., Ltd.·On the market·10 countries
Swedent Cross Key
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Swedent Hollow Key
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Hager & Werken Mirapost Kreuzdriver
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Hager & Werken Mirapost Hohldriver
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Perfection Plus Screw Post Key Male
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Perfection Plus Screw Post Key Female
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Directa Keys for Anchorage Posts - Cross
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Directa Keys for Anchorage Posts - Hollow
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
CLE CRUCIFORME KENT DENTAL
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
CLE CARREE KENT DENTAL
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Dental Cross Key
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
CLE CRUCIFORME R&S
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
CLE CARREE R&S
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
PoloDent Screw Post Key Cross
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
PoloDent Screw Post Key Hollow
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Ancorex Cross Key
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Ancorex Hollow Key
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Dental Hollow Key
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Nordin Cross Key
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Nordin Hollow Key
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Blue Blue Radar Articulating Paper Curved, 65 ยตm
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
XXXThin Blue Red Radar Articulating Paper Horseshoe, 40 ยตm
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
XXXThin Blue Red Radar Articulating Paper Curved, 40 ยตm
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Blue Red Radar Articulating Paper Horseshoe, 65 ยตm
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Blue Red Radar Articulating Paper Curved, 65 ยตm
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Blue Blue Radar Articulating Paper Horseshoe, 65 ยตm
Device
EU MDR
·
Eu Md Class 1
·Harald Nordin S.A.·On the market
Micro-Sample Test Kit
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market
Sample Tubes & Probe Wipes, 1x250
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market
Sample Tube โ Plastic 0.2ml, 1x500
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market
12mm X 75mm Primary Sample Tubs, Box Of 250
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market
A2O Sample Tubes, Box Of 500
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market
Disposable Sample Tubes
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market
Pipette Tips with Graduations 5-200 ฮผL
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market
20 Microliter Pipette
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market
Ease-Eject Sampler
Device
EU IVDR
·
Eu Ivd Class A
·Advanced Instruments, LLC·On the market