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A. V. Fistula Sets GR-2216E/1316E
EUDAMEDClass IIa (EU MDR)
Ref GR-2216E/1316EModel A. V. Fistula Sets GR-2216E/1316ERef GR-2216EModel A. V. Fistula Sets GR-2216E
Identity
- Device Name
- A. V. Fistula Sets GR-2216E/1316E EUDAMEDA. V. Fistula Sets GR-2216E EUDAMED
- Model / Reference
- A. V. Fistula Sets GR-2216E/1316E EUDAMEDGR-2216E/1316E EUDAMEDA. V. Fistula Sets GR-2216E EUDAMEDGR-2216E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488877248 EUDAMED04987488872649 EUDAMED
- Basic UDI-DI
- B-04987488877248 EUDAMEDB-04987488872649 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 GR-2216E/1316E 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-04987488877248 | 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 71397ebe-6ca3-4ed0-bfc4-216c67da903b 61 fields · synced Jul 11, 2026
- EUDAMED 4397b35d-7a03-4560-bfd9-f2f747e42f4b 61 fields · synced May 19, 2026