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Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE
EUDAMEDClass IIa (EU MDR)
Ref GF-5585E
Identity
- Trade Name
- Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE EUDAMED
- Device Name
- Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE EUDAMED
- Model / Reference
- GF-5585E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488097851 EUDAMED
- Basic UDI-DI
- 4987488AVF_PAINLESS_6Z EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE by Sb-Kawasumi Laboratories, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4987488AVF_PAINLESS_6Z | Class IIa | Unknown |
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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 b6fa9cf0-8e63-4f63-b492-fb7273148d7e 61 fields · synced Jun 17, 2026