← Back to catalogue
Hemodialysis Catheter
EUDAMEDClass IIa (EU MDR)
Ref 032014Model Double lumen 8Fx13cm Curved extension tube
Identity
- Device Name
- Hemodialysis Catheter EUDAMED
- Model / Reference
- Double lumen 8Fx13cm Curved extension tube EUDAMED032014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971162817505 EUDAMED
- Basic UDI-DI
- B-06971162817505 EUDAMED
- EMDN Code
- F900201 TEMPORARY HEMODIALYSIS CATHETERS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hemodialysis Catheter by Tianck Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971162817505 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fec327d6-afea-40d8-b6af-5a808645826d 61 fields · synced Jun 18, 2026