Identity
- Trade Name
- ORAL SWAB EUDAMED
- Device Name
- ORAL SWAB EUDAMED
- Model / Reference
- LY-OS00 EUDAMEDLY-OS02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975394400818 EUDAMED
- Basic UDI-DI
- 697539440LYOS00YE EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Oral Swab by Linye Health Tech(ningbo)co., Ltd — Class I — CE/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 | 697539440LYOS00YE | Class I | Active |
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Manufacturer
- Manufacturer
- Linye Health Tech(ningbo)co., Ltd
- EUDAMED SRN
- CN-MF-000024232
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 9e249694-b3e1-44de-8602-a697722ac8d4 61 fields · synced Oct 7, 2026