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Closed Suction Systems
EUDAMEDClass IIa (EU MDR)
Ref 8Fr（CSS-A08PY）Model XTGRef NA
Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED8Fr（CSS-A08PY） EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970531334084 EUDAMED26970531334890 EUDAMED06970531334902 EUDAMED36970531332343 EUDAMED06970531334896 EUDAMED16970531332349 EUDAMED26970531334906 EUDAMED26970531334081 EUDAMED06970531332342 EUDAMED06970531334285 EUDAMED26970531334289 EUDAMED06970531334087 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 16970531334084 EUDAMED26970531334890 EUDAMED06970531334902 EUDAMED36970531332343 EUDAMED06970531334896 EUDAMED16970531332349 EUDAMED26970531334906 EUDAMED26970531334081 EUDAMED06970531332342 EUDAMED06970531334285 EUDAMED26970531334289 EUDAMED06970531334087 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 (15)
- EUDAMED 1502c50a-7a8c-4619-bfe6-3a5c0caa51ad 61 fields · synced Oct 7, 2026
- EUDAMED 4fd54150-b76f-4ca9-8cf0-d27e181b1373 61 fields · synced May 17, 2026
- EUDAMED 7a1a7b9c-c822-4066-9011-de12c550480c 61 fields · synced May 17, 2026
- EUDAMED 6adb021a-d622-4dde-b314-a9140335a30f 61 fields · synced May 18, 2026
- EUDAMED ca3400ab-cdfe-4909-beed-bbd26e9213ff 61 fields · synced May 18, 2026
- EUDAMED 60efa055-c619-4249-abc6-5da483a1f38a 61 fields · synced May 19, 2026
- EUDAMED 55c085ef-5044-40dd-8296-bbcc29f872c8 61 fields · synced May 19, 2026
- EUDAMED aed1745b-79c5-444c-8336-be738e8ccb2f 61 fields · synced May 19, 2026
- EUDAMED 98428458-fc3b-42c4-ab40-e841a336a151 61 fields · synced May 19, 2026
- EUDAMED e773e20e-9f45-441b-8865-59e99ca8fd11 61 fields · synced May 19, 2026
- EUDAMED 59102821-1ee9-4d44-8fe8-c395cb446464 61 fields · synced May 19, 2026
- EUDAMED 90e705e4-f066-4cf6-9ab7-0d8eaddbae8f 61 fields · synced May 19, 2026
- EUDAMED 59657a13-a6e6-4e4c-9b64-9d15b0085681 61 fields · synced Jul 9, 2026
- EUDAMED fe9b7b2f-546c-4bc8-9800-5ab21ac0c4f5 61 fields · synced Jul 28, 2026
- EUDAMED 39e871fc-535b-4764-97de-38418e3e77db 61 fields · synced Aug 2, 2026