Identity
- Trade Name
- Colli-Pee® FV-5010 EUDAMEDColli-Pee FDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- Colli-Pee® FV-5020 EUDAMEDUrine Collection Container FDA UDI
- Model / Reference
- N00309 EUDAMEDColli-Pee FV-5010 FDA UDI
- Description
- Urine Collection Container FDA UDI
Identifiers
- Catalog Number
- N00309 FDA UDI
- Primary DI / UDI-DI
- 00627595001634 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627595K1100J4 EUDAMED
- FDA Product Code
- NNK FDA UDI
- EMDN Code
- W05010299 URINE COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Austria 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Colli-Pee® FV-5010 by DNA Genotek 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 | 0627595K1100J4 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- DNA Genotek Inc.
- EUDAMED SRN
- CA-MF-000003486
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED f5a6e3cc-2ae8-43ef-b658-7e823d571cd9 61 fields · synced Jul 8, 2026
- FDA UDI 45f6bdd9-0a1f-484a-bfcd-5b643280c06b 35 fields · synced May 30, 2026