Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED16Fr（CSS-A16TY） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970531334746 EUDAMED16970531334046 EUDAMED06970531334742 EUDAMED16970531332301 EUDAMED16970531334732 EUDAMED26970531334043 EUDAMED36970531332305 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 26970531334746 EUDAMED16970531334046 EUDAMED06970531334742 EUDAMED16970531332301 EUDAMED16970531334732 EUDAMED26970531334043 EUDAMED36970531332305 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 7dd68b46-efb8-4957-b66f-ca43b23b6e4a 61 fields · synced Oct 7, 2026
- EUDAMED 242402bc-37dd-4cc5-86c4-20544c6f6f6e 61 fields · synced May 17, 2026
- EUDAMED 2ecc294f-8223-41e9-a639-b3b4352b5291 61 fields · synced May 17, 2026
- EUDAMED 9278a50c-6b6a-4bea-a281-c3edb163a879 61 fields · synced May 18, 2026
- EUDAMED b1c4da60-77be-4bca-9cb6-94e25f8070a7 61 fields · synced May 19, 2026
- EUDAMED e2b69f2c-7a42-4a1c-8961-be142be2c045 61 fields · synced May 19, 2026
- EUDAMED cc0c0fdf-3efa-46b5-9d31-4f1dc70f60eb 61 fields · synced May 19, 2026