Identity
- Trade Name
- RapiHem UTRWALACZ 2,5L EUDAMED
- Device Name
- Odczynniki do barwienia krwi EUDAMED
- Model / Reference
- 1022.8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05906492940488 EUDAMED
- Basic UDI-DI
- 590649294ODBKLE EUDAMED
- EMDN Code
- W0103010302 ROMANOWSKY STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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
RapiHem UTRWALACZ 2, 5L by Kolasa Spółka Jawna — Class A — 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 | 590649294ODBKLE | Class A | Active |
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Manufacturer
- Manufacturer
- Kolasa Spółka Jawna
- EUDAMED SRN
- PL-MF-000044993
Sources (1)
- EUDAMED 390bcb75-cd55-4543-be5c-744c2e2c1e98 61 fields · synced Jul 25, 2026