Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED14Fr（CSS-A14EY） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970531335015 EUDAMED06970531335022 EUDAMED36970531332374 EUDAMED06970531334117 EUDAMED26970531334111 EUDAMED16970531335012 EUDAMED26970531335019 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 06970531335015 EUDAMED06970531335022 EUDAMED36970531332374 EUDAMED06970531334117 EUDAMED26970531334111 EUDAMED16970531335012 EUDAMED26970531335019 EUDAMED
- EMDN Code
- R050102 CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
Closed Suction Systems by Shaoxing Undis Medical Technology Co., Ltd — Class IIa — 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 | 697053133cssXK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Undis Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000002187
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (7)
- EUDAMED 191f48f4-990c-42d1-84b8-272dbb499bbf 61 fields · synced Oct 7, 2026
- EUDAMED 8f80c3f5-0bb3-42d7-a02e-07a47f74205d 61 fields · synced May 17, 2026
- EUDAMED eca712ab-3f9d-4f09-ab04-8289a49bbde4 61 fields · synced May 17, 2026
- EUDAMED adb1d5fd-31f7-4522-9b25-d0f44b381b1c 61 fields · synced May 17, 2026
- EUDAMED 61d65ae4-1102-476a-9674-61331ed9505c 61 fields · synced May 18, 2026
- EUDAMED 5ced4965-68df-4f46-8fbc-1c176033b82e 61 fields · synced May 18, 2026
- EUDAMED a91918ca-d3ad-438e-acc2-f39b50d86712 61 fields · synced May 18, 2026