Identity
- Trade Name
- Probówki na 1ml krwi, z EDTA-K2 EUDAMED
- Device Name
- Probówki do badań hematologicznych krwi EUDAMED
- Model / Reference
- 32-0301-2E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05905699560086 EUDAMED
- Basic UDI-DI
- 5905072235071Z8 EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES 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
No
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
Category: General specimen collection kit
Probówki na 1ml krwi, z EDTA-K2 by MEDLAB-PRODUCTS Sp. z o.o. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5905072235071Z8 | Class A | Active |
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Manufacturer
- Manufacturer
- MEDLAB-PRODUCTS Sp. z o.o.
- EUDAMED SRN
- PL-MF-000028388
Sources (1)
- EUDAMED 5f97b66d-f54a-4a82-a7d3-8440d5ac8e46 61 fields · synced Aug 2, 2026