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Closed Suction Systems
EUDAMEDClass IIa (EU MDR)
Ref 16Fr（CSS-A16EY）Model XTGRef NA
Identity
- Trade Name
- Closed Suction Systems EUDAMED
- Device Name
- Closed Suction Systems EUDAMED
- Model / Reference
- XTG EUDAMED16Fr（CSS-A16EY） EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970531335057 EUDAMED16970531332387 EUDAMED06970531335060 EUDAMED26970531335064 EUDAMED06970531334124 EUDAMED16970531334121 EUDAMED26970531334128 EUDAMED26970531332384 EUDAMED16970531335067 EUDAMED06970531335053 EUDAMED06970531332380 EUDAMED
- Basic UDI-DI
- 697053133cssXK EUDAMED
- Direct Marketing DI
- 26970531335057 EUDAMED16970531332387 EUDAMED06970531335060 EUDAMED26970531335064 EUDAMED06970531334124 EUDAMED16970531334121 EUDAMED26970531334128 EUDAMED26970531332384 EUDAMED16970531335067 EUDAMED06970531335053 EUDAMED06970531332380 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 (14)
- EUDAMED 7c80e2fc-f83d-44ac-b5f4-8fe38d48e2a5 61 fields · synced Oct 7, 2026
- EUDAMED d74c688f-265e-424a-82f8-5c5f14bc6f6e 61 fields · synced May 11, 2026
- EUDAMED 81c08472-c819-46ec-bf42-ba1f0c934310 61 fields · synced May 16, 2026
- EUDAMED 12700492-f8d5-4f98-9eeb-ac47d979f0a5 61 fields · synced May 16, 2026
- EUDAMED f2c46665-4540-4eb2-908b-8601a4d2d17e 61 fields · synced May 16, 2026
- EUDAMED ae6b323f-10ad-4f64-b7f9-22f54405e6e0 61 fields · synced May 17, 2026
- EUDAMED 0a13c052-b4c1-464a-b954-76f11977e096 61 fields · synced May 17, 2026
- EUDAMED 1faca622-dca5-4d29-8100-5cb8fd525537 61 fields · synced May 17, 2026
- EUDAMED c982aeaa-8e62-499e-8cfb-4c7b3a553569 61 fields · synced May 19, 2026
- EUDAMED 461ae402-49b8-40be-bc0f-d7f441a2ed37 61 fields · synced May 19, 2026
- EUDAMED aabe2af0-f1e9-4613-8325-960d9e8a11ac 61 fields · synced May 19, 2026
- EUDAMED 820960e8-ca0b-41a8-b658-27792e867dd3 61 fields · synced Jul 15, 2026
- EUDAMED 3c4a3e7e-9ceb-432a-87bd-7db1386a3c40 61 fields · synced Jul 18, 2026
- EUDAMED 201c04a5-924b-4927-87e1-2d35e859cdb6 61 fields · synced Sep 17, 2026