Identity
- Trade Name
- REP/SPIFE SP 600 Kit EUDAMED
- Device Name
- Serum Protein Kits EUDAMED
- Model / Reference
- 3145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056013011538 EUDAMED
- Basic UDI-DI
- 5056013005BANDM8 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
REP/SPIFE SP 600 Kit 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 | 5056013005BANDM8 | 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 62901567-fc9c-49ab-8e56-383c6f24e12c 61 fields · synced Jun 18, 2026