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A. V. Fistula Sets GF-5328E
EUDAMEDClass IIa (EU MDR)
Ref GF-5328EModel A. V. Fistula Sets GF-5328ERef GF-5326EModel A. V. Fistula Sets GF-5326E
Identity
- Device Name
- A. V. Fistula Sets GF-5328E EUDAMEDA. V. Fistula Sets GF-5326E EUDAMED
- Model / Reference
- A. V. Fistula Sets GF-5328E EUDAMEDGF-5328E EUDAMEDA. V. Fistula Sets GF-5326E EUDAMEDGF-5326E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488870362 EUDAMED04987488870324 EUDAMED
- Basic UDI-DI
- B-04987488870362 EUDAMEDB-04987488870324 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
A. V. Fistula Sets GF-5328E by Sb-Kawasumi Laboratories, Inc. — 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-04987488870362 | Class IIa | 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 (2)
- EUDAMED 4e758539-e8ac-49e8-81f2-04fefe68afe3 61 fields · synced Aug 1, 2026
- EUDAMED a5f26ba6-ffad-429e-a21f-d0ccfe336f84 61 fields · synced May 18, 2026