Authorized Representative
🇳🇱 Netherlands
Active
Qualrep Services B.V.
SRN: NL-AR-000000537
·
Utrechtseweg 310 Bldg B42, 6812 AR Arnhem, Netherlands
Manufacturers
24
Devices
43
Certificates
4
PRRCs
1
Basic Information
- Address
- Utrechtseweg 310 Bldg B42, 6812 AR Arnhem, Netherlands
- [email protected]
- VAT Number
- NL814785505B01
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Starpharma Pty Ltd | 🇦🇺 Australia | AU-MF-000012162 |
| Adagio Medical, Inc. | 🇺🇸 United States | US-MF-000001129 |
| Santa Barbara Imaging Systems, Inc. | 🇺🇸 United States | US-MF-000007262 |
| Honsin Apparel Sdn. Bhd. | 🇲🇾 Malaysia | MY-MF-000008637 |
| GestVision, Inc. | 🇺🇸 United States | US-MF-000008873 |
| Typenex Medical, LLC | 🇺🇸 United States | US-MF-000024001 |
| ABU DHABI MEDICAL DEVICES CO. LLC. | 🇦🇪 United Arab Emirates | AE-MF-000028318 |
| GBUK Group | 🇬🇧 United Kingdom | GB-MF-000002238 |
| Speclipse, Inc. | 🇰🇷 South Korea | KR-MF-000026775 |
| Franklin-AI Pty Ltd | 🇦🇺 Australia | AU-MF-000034387 |
| Whitney Medical Solutions | 🇺🇸 United States | US-MF-000037506 |
| PROCEPT BioRobotics Corporation | 🇺🇸 United States | US-MF-000015560 |
| Anteris Aus Operations Pty Ltd | 🇦🇺 Australia | AU-MF-000032471 |
| VistaPath Biosystems, Inc. | 🇺🇸 United States | US-MF-000039863 |
| Conformal Medical, Inc. | 🇺🇸 United States | US-MF-000040562 |
| System C Healthcare Limited | 🇬🇧 United Kingdom | UK-MF-000042963 |
| Microbio Ltd | 🇦🇺 Australia | AU-MF-000033903 |
| Univfy Inc. | 🇺🇸 United States | US-MF-000046344 |
| Cendres+Métaux SA | 🇨🇭 Switzerland | CH-MF-000030696 |
| GRAIL, Inc | 🇺🇸 United States | US-MF-000012088 |
| Annalise-AI Pty Ltd | 🇦🇺 Australia | AU-MF-000010247 |
| KA Imaging Inc. | 🇨🇦 Canada | CA-MF-000030642 |
| SeeTreat Pty Ltd | 🇦🇺 Australia | AU-MF-000045001 |
| PolyGel LLC | 🇺🇸 United States | US-MF-000008436 |
Manufacturers
Microbio Ltd
Manufacturer
🇦🇺 Australia
PROCEPT BioRobotics Corporation
Manufacturer
🇺🇸 United States·1 Importer
KA Imaging Inc.
Manufacturer
🇨🇦 Canada·1 Basic UDI-DI·1 Device
Annalise-AI Pty Ltd
Manufacturer
🇦🇺 Australia·2 Basic UDI-DIs·4 Devices
Cendres+Métaux SA
Manufacturer
🇨🇭 Switzerland·3 Importers
Santa Barbara Imaging Systems, Inc.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·10 Devices·1 Importer
Univfy Inc.
Manufacturer
🇺🇸 United States
Franklin-AI Pty Ltd
Manufacturer
🇦🇺 Australia
Whitney Medical Solutions
Manufacturer
🇺🇸 United States
GRAIL, Inc
Manufacturer
🇺🇸 United States
Speclipse, Inc.
Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·DNV Product Assurance AS
PolyGel LLC
Manufacturer
🇺🇸 United States
System C Healthcare Limited
ManufacturerGestVision, Inc.
Manufacturer
🇺🇸 United States
GBUK Group
Manufacturer
13 Importers
Honsin Apparel Sdn. Bhd.
Manufacturer
🇲🇾 Malaysia
Anteris Aus Operations Pty Ltd
Manufacturer
🇦🇺 Australia
Adagio Medical, Inc.
Manufacturer
🇺🇸 United States·25 Basic UDI-DIs·25 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
VistaPath Biosystems, Inc.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device
SeeTreat Pty Ltd
Manufacturer
🇦🇺 Australia
Conformal Medical, Inc.
Manufacturer
🇺🇸 United States
ABU DHABI MEDICAL DEVICES CO. LLC.
Manufacturer
🇦🇪 United Arab Emirates
Typenex Medical, LLC
Manufacturer
🇺🇸 United States·2 Importers
Starpharma Pty Ltd
Manufacturer
🇦🇺 Australia·1 Basic UDI-DI·1 Device·1 Importer
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 289521-2019-CE-KOR-NA-PS | Speclipse, Inc. | DNV Product Assurance AS | Expired |
| MDD Annex II (excluding section 4) | G1S 103403 0004 | Adagio Medical, Inc. | TÜV SÜD Product Service GmbH | Expired |
| MDD Annex II Section 4 | G7 103403 0005 | Adagio Medical, Inc. | TÜV SÜD Product Service GmbH | Expired |
| MDD Annex II (excluding section 4) | G1 103403 0002 | Adagio Medical, Inc. | TÜV SÜD Product Service GmbH | Expired |
Devices
Reveal 35C
Device
EU MDR
·
Eu Md Class 2a
·KA Imaging Inc.·On the market·1 country
Annalise Container
Device
EU MDR
·
Eu Md Class 2b
·Annalise-AI Pty Ltd·On the market·2 countries
Annalise Container
Device
EU MDR
·
Eu Md Class 2b
·Annalise-AI Pty Ltd·On the market·2 countries
Annalise Enterprise
Device
EU MDR
·
Eu Md Class 2b
·Annalise-AI Pty Ltd·On the market·1 country
Annalise Enterprise
Device
EU MDR
·
Eu Md Class 2b
·Annalise-AI Pty Ltd·On the market·1 country
Omni
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
Omni
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
Omni
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
PIxa
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
Pixa
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
Pixa
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
Pixa
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
Pixa
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
Pixa
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
Pixa
Device
EU MDR
·
Eu Md Class 1
·Santa Barbara Imaging Systems, Inc.·On the market·32 countries
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Speclipse, Inc.·On the market·1 country
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
Adagio iCLAS™ Shaped Stylets
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Shaped Stylet Accesory
Device
EU MDD
·
Eu Md Class 1
·Adagio Medical, Inc.·On the market·5 countries
iCLAS™ Cryoablation Catheter
Device
EU MDD
·
Eu Md Class 3
·Adagio Medical, Inc.·On the market·5 countries
Esophageal Warming Balloon Catheter
Device
EU MDD
·
Eu Md Class 2a
·Adagio Medical, Inc.·On the market·5 countries
VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·VistaPath Biosystems, Inc.·On the market
VIRALEZE™
Device
EU MDD
·
Eu Md Class 1
·Starpharma Pty Ltd·On the market