Identity
- Trade Name
- VERSATREK CONNECTOR EUDAMEDVersaTREK™ FDA UDI
- Generic Name
- Blood culture analyser IVD FDA UDI
- Device Name
- VERSATREK CONNECTOR EUDAMED
- Model / Reference
- 7150-44 EUDAMEDVersaTREK™ Connector 7150-44 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838091841 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380VersaTrekConnectU6 EUDAMED
- FDA Product Code
- MDB FDA UDI
- EMDN Code
- W05030380 MICROBIOLOGY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Blood culture analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Versatrek Connector by Remel, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8488380VersaTrekConnectU6 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 4a5e0144-bfb3-4a56-86b9-bb02b4f12de3 61 fields · synced Jun 18, 2026
- FDA UDI 07ed7edd-ec22-4cc9-a092-ff8b29e40a2f 32 fields · synced May 30, 2026