Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED16Fr（CSS-B16TY） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970531332588 EUDAMED06970531335534 EUDAMED06970531334247 EUDAMED16970531335531 EUDAMED16970531335548 EUDAMED26970531332582 EUDAMED06970531335541 EUDAMED16970531332585 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 06970531332588 EUDAMED06970531335534 EUDAMED06970531334247 EUDAMED16970531335531 EUDAMED16970531335548 EUDAMED26970531332582 EUDAMED06970531335541 EUDAMED16970531332585 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 (8)
- EUDAMED 16964a7d-1b89-4a1f-8c8a-4ead6b924d5f 61 fields · synced Oct 7, 2026
- EUDAMED cf1ede0b-2a2a-4ea7-adcc-80992f6ca2cd 61 fields · synced May 16, 2026
- EUDAMED 1fbfb302-23fe-4a2a-ba3b-976893415e53 61 fields · synced May 17, 2026
- EUDAMED d8db7ba2-e4f3-4f1d-8b50-21f25fe123ea 61 fields · synced May 17, 2026
- EUDAMED 430c2c39-17e5-4bee-8cac-d4bba9b47152 61 fields · synced May 19, 2026
- EUDAMED 999a5e5a-adf2-45a1-9542-9395fec7cfaf 61 fields · synced May 19, 2026
- EUDAMED 0afb0a15-772d-4873-a78e-81962014075e 61 fields · synced May 19, 2026
- EUDAMED fd092ee0-073f-41fc-8ec8-1335e402ce34 61 fields · synced May 19, 2026