Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED12Fr（CSS-A12TY） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970531334025 EUDAMED06970531334650 EUDAMED06970531334667 EUDAMED16970531332288 EUDAMED26970531334654 EUDAMED36970531332282 EUDAMED26970531332285 EUDAMED06970531332281 EUDAMED16970531334657 EUDAMED26970531334029 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 06970531334025 EUDAMED06970531334650 EUDAMED06970531334667 EUDAMED16970531332288 EUDAMED26970531334654 EUDAMED36970531332282 EUDAMED26970531332285 EUDAMED06970531332281 EUDAMED16970531334657 EUDAMED26970531334029 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 (10)
- EUDAMED b5218d70-2788-42bb-b775-2a1b78df0151 61 fields · synced Oct 7, 2026
- EUDAMED 3da7c7e4-3459-415c-bd20-337e4d6aacea 61 fields · synced May 17, 2026
- EUDAMED 86917327-1144-46d6-8c97-ca4d0b7a7cc5 61 fields · synced May 17, 2026
- EUDAMED b5e0ea90-5c66-4c9c-91ca-4afc159b2214 61 fields · synced May 17, 2026
- EUDAMED b9a875fc-f908-42a4-9362-b5b7995f84fd 61 fields · synced May 18, 2026
- EUDAMED 4d5b7a1d-386d-48ba-91fa-5846f2394293 61 fields · synced May 18, 2026
- EUDAMED 4c8e799b-a085-404e-97b6-414522b0026a 61 fields · synced May 19, 2026
- EUDAMED 33fb3cbe-7310-4c98-8f88-9a19acba5f80 61 fields · synced May 19, 2026
- EUDAMED 22b8d7e6-e780-48da-8ceb-1c9024021189 61 fields · synced May 19, 2026
- EUDAMED dad45d88-fc63-4c33-9e0a-f38835508885 61 fields · synced May 19, 2026