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Drainage Catheter
EUDAMEDClass IIa (EU MDR)
Ref 215003Model 4F, 6F, 7F, 8F, 8.5F, 9F, 10F, 12F, 14F, 16F, 18F, 20F, 22F, 24F, 28F
Identity
- Device Name
- Drainage Catheter EUDAMED
- Model / Reference
- 4F, 6F, 7F, 8F, 8.5F, 9F, 10F, 12F, 14F, 16F, 18F, 20F, 22F, 24F, 28F EUDAMED215003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971162819233 EUDAMED
- Basic UDI-DI
- 697116281DC21D2 EUDAMED
- EMDN Code
- A060206 PERITONAEAL DRAINAGES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Drainage Catheter by Tianck Medical 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 | 697116281DC21D2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED f92b6d4a-bee5-48cd-b8b2-39234ae5e9da 61 fields · synced Jun 19, 2026