Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970531332315 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- EMDN Code
- R050102 CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) EUDAMED
Classification
- Device Class
- Class IIa 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 14e1bc56-fbab-45c8-93ea-f71018d6ae5f 61 fields · synced Jun 19, 2026