Identity
- Trade Name
- Probówki do OB na 1ml krwi, z nalepką EUDAMED
- Device Name
- Probówki do oznaczania OB EUDAMED
- Model / Reference
- 32-0401-3N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05905699560192 EUDAMED
- Basic UDI-DI
- 5905072235064ZB 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 do OB na 1ml krwi, z nalepką 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 | 5905072235064ZB | Class A | Active |
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Manufacturer
- Manufacturer
- MEDLAB-PRODUCTS Sp. z o.o.
- EUDAMED SRN
- PL-MF-000028388
Sources (1)
- EUDAMED 878c583c-2945-4a0d-a066-1017b5e1e2b2 61 fields · synced Jun 19, 2026