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A. V. Fistula Sets GR-2238E/1338E
EUDAMEDClass IIa (EU MDR)
Ref GR-2238E/1338EModel A. V. Fistula Sets GR-2238E/1338E
Identity
- Device Name
- A. V. Fistula Sets GR-2238E/1338E EUDAMED
- Model / Reference
- A. V. Fistula Sets GR-2238E/1338E EUDAMEDGR-2238E/1338E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488880873 EUDAMED
- Basic UDI-DI
- B-04987488880873 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
The A. V. Fistula Sets GR-2238E/1338E device is a medical technology solution designed for the treatment of fistulas, providing a safe and effective alternative to traditional procedures. This device has undergone rigorous testing and meets the highest standards of medical innovation and patient care.
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-04987488880873 | 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 (1)
- EUDAMED 284b476d-a978-4266-b3fb-7bdfbaa7f7d9 61 fields · synced Jul 29, 2026