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Closed Suction Systems
EUDAMEDClass IIa (EU MDR)
Ref NAModel XTGRef 12Fr（CSS-B12EY）
Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMEDNA EUDAMED12Fr（CSS-B12EY） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970531332458 EUDAMED06970531334186 EUDAMED16970531335302 EUDAMED16970531334183 EUDAMED26970531332452 EUDAMED06970531335305 EUDAMED26970531334180 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 06970531332458 EUDAMED06970531334186 EUDAMED16970531335302 EUDAMED16970531334183 EUDAMED26970531332452 EUDAMED06970531335305 EUDAMED26970531334180 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 (9)
- EUDAMED fc6432ac-d7f8-4e4e-9509-489416c3122d 61 fields · synced Oct 7, 2026
- EUDAMED bf4b7797-40a4-4301-abf9-6168aa8d15c6 61 fields · synced May 17, 2026
- EUDAMED 1b4cc117-9b30-4be7-8442-2cc21a7180d3 61 fields · synced May 17, 2026
- EUDAMED 7251bd00-32a5-40d9-b8c7-0ca8d9f4fa90 61 fields · synced May 17, 2026
- EUDAMED 51ecbfa1-99ac-478c-89b1-a1c342d4b1e0 61 fields · synced May 19, 2026
- EUDAMED 54ce2d26-03d4-471b-824d-a14d5e61a599 61 fields · synced May 19, 2026
- EUDAMED 61ab02d2-a035-4077-ad72-6bc8fe135282 61 fields · synced May 19, 2026
- EUDAMED 5cacc63b-88fa-4077-95b1-7b8e2810972d 61 fields · synced Jul 30, 2026
- EUDAMED dd893e4d-fa27-4110-bf4b-38e321de6c71 61 fields · synced Aug 3, 2026