Identity
- Trade Name
- CITOTEST EUDAMED
- Device Name
- Embedding Cassettes EUDAMED
- Model / Reference
- P.O.M EUDAMED0121-1130-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942826211373 EUDAMED
- Basic UDI-DI
- 697079159TECA000A00NF4 EUDAMED
- EMDN Code
- W05030501 INCLUSION DEVICES, CASSETTES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Citotest by Citotest Labware Manufacturing Co., Ltd — 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 | 697079159TECA000A00NF4 | Class A | Active |
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Manufacturer
- Manufacturer
- Citotest Labware Manufacturing Co., Ltd
- EUDAMED SRN
- CN-MF-000017214
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 193742f6-ffe4-4dbf-b8e4-0891038de056 61 fields · synced Jun 18, 2026