Identity
- Trade Name
- A. V. Fistula Sets for Hemodialysis EUDAMED
- Device Name
- A. V. Fistula Sets for Hemodialysis EUDAMED
- Model / Reference
- AVF1625CLFG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488097929 EUDAMED
- Basic UDI-DI
- 4987488AVF_HD_KR EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
A. V. Fistula Sets for Hemodialysis 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_HD_KR | Class IIa | Unknown |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sb-Kawasumi Laboratories, Inc.
- EUDAMED SRN
- JP-MF-000011253
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED a61430f6-7822-4b66-98e8-18c39130f063 61 fields · synced Jun 18, 2026