Identity
- Trade Name
- CITOTEST EUDAMED
- Device Name
- Classical swabs EUDAMED
- Model / Reference
- Polyester EUDAMED2125-0007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975085648130 EUDAMED
- Basic UDI-DI
- 697079159SWA1000A02GKU EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS 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
Category: General-purpose absorbent tip applicator/swab, single-use
Citotest by Citotest Labware Manufacturing Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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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 | 697079159SWA1000A02GKU | 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 53540df6-8095-4f86-b646-5a2f948e8d32 61 fields · synced Jun 18, 2026