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Hollow Fiber Dialyzer- RENAK-CTA CTA-2000
EUDAMEDClass IIb (EU MDR)
Ref CTA-2000Model Hollow Fiber Dialyzer- RENAK-CTA CTA-2000
Identity
- Device Name
- Hollow Fiber Dialyzer- RENAK-CTA CTA-2000 EUDAMED
- Model / Reference
- Hollow Fiber Dialyzer- RENAK-CTA CTA-2000 EUDAMEDCTA-2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488861308 EUDAMED
- Basic UDI-DI
- B-04987488861308 EUDAMED
- EMDN Code
- F01060202 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece 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
Hollow Fiber Dialyzer- RENAK-CTA CTA-2000 by Sb-Kawasumi Laboratories, Inc. — Class IIb — 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-04987488861308 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sb-Kawasumi Laboratories, Inc.
- EUDAMED SRN
- JP-MF-000011253
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED b4af587b-ddec-4a18-9a2b-5aa8a327f48b 61 fields · synced Jul 21, 2026