Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED14Fr（CSS-A14TY） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970531334036 EUDAMED26970531334708 EUDAMED16970531334701 EUDAMED06970531334698 EUDAMED26970531332292 EUDAMED26970531334692 EUDAMED16970531334695 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 26970531334036 EUDAMED26970531334708 EUDAMED16970531334701 EUDAMED06970531334698 EUDAMED26970531332292 EUDAMED26970531334692 EUDAMED16970531334695 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 087e64f5-62db-4088-b6d5-09b32a802f2d 61 fields · synced Oct 7, 2026
- EUDAMED de06d3bf-1d03-4ed6-80d7-0b23acfc503e 61 fields · synced May 17, 2026
- EUDAMED 365d90b2-ad30-4dd7-9871-c970002fd7c1 61 fields · synced May 17, 2026
- EUDAMED 78599f72-18de-478b-b78a-5f9cd1454b8d 61 fields · synced May 19, 2026
- EUDAMED 6f596fac-cf32-46c6-8d0d-8cf3275a797b 61 fields · synced May 19, 2026
- EUDAMED a152fc89-d8cf-44ca-a18e-1195b21866e9 61 fields · synced May 19, 2026
- EUDAMED 24e5a817-e56c-4e32-8215-2d2927adc07a 61 fields · synced May 19, 2026