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Arterial Venous Fistula Set
EUDAMEDClass IIa (EU MDR)
Ref GR-5306EMGRef GR-6116ERef GF-6126ERef GF-5015E
Identity
- Trade Name
- Arterial Venous Fistula Set EUDAMED
- Device Name
- Arterial Venous Fistula Set EUDAMED
- Model / Reference
- GR-5306EMG EUDAMEDGR-6116E EUDAMEDGF-6126E EUDAMEDGF-5015E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488097349 EUDAMED04987488103989 EUDAMED04987488096908 EUDAMED04987488097042 EUDAMED
- Basic UDI-DI
- 4987488AVF_F9 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 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 Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4987488AVF_F9 | 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 (4)
- EUDAMED 6cf46a80-a565-435d-8b35-3acaa61ffdad 61 fields · synced Sep 18, 2026
- EUDAMED 778a0909-fefb-48ab-9395-159920a77a1f 61 fields · synced May 16, 2026
- EUDAMED 1f288c9f-b9fd-4714-ac9f-cdeab55e3054 61 fields · synced May 17, 2026
- EUDAMED f1c42f47-5386-432a-afa9-c21476dbf1cc 61 fields · synced May 18, 2026