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Closed Suction Systems
EUDAMEDClass IIa (EU MDR)
Ref 10Fr（CSS-B10EY）Model XTGRef NA
Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED10Fr（CSS-B10EY） EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970531334179 EUDAMED26970531335255 EUDAMED16970531335258 EUDAMED16970531332448 EUDAMED26970531332445 EUDAMED26970531334173 EUDAMED26970531335262 EUDAMED16970531334176 EUDAMED16970531335265 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 06970531334179 EUDAMED26970531335255 EUDAMED16970531335258 EUDAMED16970531332448 EUDAMED26970531332445 EUDAMED26970531334173 EUDAMED26970531335262 EUDAMED16970531334176 EUDAMED16970531335265 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 (11)
- EUDAMED b8069f92-8af4-43b0-b227-2e193c5bd06d 61 fields · synced Oct 7, 2026
- EUDAMED 5de63ed1-bf87-418e-96d1-d58d434b08b1 61 fields · synced May 16, 2026
- EUDAMED 4e7e6b62-48d9-443a-b33b-7d8e096a82ea 61 fields · synced May 16, 2026
- EUDAMED ab385641-de02-4e9c-ba75-3cfcf0fa3e60 61 fields · synced May 16, 2026
- EUDAMED aea5d021-4ecd-43c5-b58e-68146f2fdc63 61 fields · synced May 17, 2026
- EUDAMED bc62c2fc-cc6d-42ae-b80b-bc84e7a51324 61 fields · synced May 17, 2026
- EUDAMED fc2b9390-52f0-4ef0-a9f2-6a17721bdd9d 61 fields · synced May 17, 2026
- EUDAMED d8c85736-a63e-464f-a9ee-df4baa8df531 61 fields · synced May 17, 2026
- EUDAMED ee6904d5-35c5-4e55-b452-0af8e36c7bee 61 fields · synced May 17, 2026
- EUDAMED f6053903-f8b0-43fb-9973-5ede57ceeb66 61 fields · synced Jul 17, 2026
- EUDAMED 64405b41-5ff6-45ce-ba55-22203aa41ad6 61 fields · synced Jul 23, 2026