Identity
- Trade Name
- CITOTEST EUDAMED
- Device Name
- Cytology brushes EUDAMED
- Model / Reference
- PE EUDAMED0010-0012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975085645436 EUDAMED
- Basic UDI-DI
- 697079159BRU1000B00GD9 EUDAMED
- EMDN Code
- U089002 DEVICES FOR GYNAECOLOGICAL CYTOLOGY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Citotest by Citotest Labware Manufacturing Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697079159BRU1000B00GD9 | Class I | 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 7f7bdf03-167d-437e-b805-2956e239904c 61 fields · synced Jun 18, 2026