Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED8Fr（CSS-A08PY） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970531334893 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 16970531334893 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 — 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 (1)
- EUDAMED 09302165-b3d3-4c07-bb21-e5c5d42a1eaa 61 fields · synced Jun 19, 2026