← Back to catalogue
A. V. Fistula Sets GF-2218E
EUDAMEDClass IIa (EU MDR)
Ref GF-2218EModel A. V. Fistula Sets GF-2218ERef GF-2218E/1318EModel A. V. Fistula Sets GF-2218E/1318E
Identity
- Device Name
- A. V. Fistula Sets GF-2218E EUDAMEDA. V. Fistula Sets GF-2218E/1318E EUDAMED
- Model / Reference
- A. V. Fistula Sets GF-2218E EUDAMEDGF-2218E EUDAMEDA. V. Fistula Sets GF-2218E/1318E EUDAMEDGF-2218E/1318E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488869700 EUDAMED04987488877217 EUDAMED
- Basic UDI-DI
- B-04987488869700 EUDAMEDB-04987488877217 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-2218E 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-04987488869700 | Class IIa | Active |
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 (2)
- EUDAMED 569b549e-2d86-45f1-8669-34335f43db0a 61 fields · synced Jul 26, 2026
- EUDAMED 26c36cc4-388f-4eb9-989f-e59cdd6e3181 61 fields · synced May 17, 2026