Identity
- Trade Name
- Thromboplastin L EUDAMED
- Device Name
- Thromboplastin L EUDAMED
- Model / Reference
- 5267L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056013016779 EUDAMED
- Basic UDI-DI
- 505601300PTMR EUDAMED
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Thromboplastin L by Helena Biosciences Europe — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 505601300PTMR | Class C | Active |
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Manufacturer
- Manufacturer
- Helena Biosciences Europe
- EUDAMED SRN
- GB-MF-000028365
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 35c2c21d-3015-4222-b4ab-825d741516c3 61 fields · synced Oct 7, 2026