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RapiHem Zestaw do szybkiego barwienia rozmazów krwi
EUDAMEDClass A (EU MDR)
Ref 0176.2
Identity
- Trade Name
- RapiHem Zestaw do szybkiego barwienia rozmazów krwi EUDAMED
- Device Name
- Odczynniki do barwienia krwi EUDAMED
- Model / Reference
- 0176.2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05906492942802 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 Zestaw do szybkiego barwienia rozmazów krwi 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 703db75a-d831-4241-b7aa-b8fcdca2fa66 61 fields · synced Oct 8, 2026