Identity
- Trade Name
- BIONIC FISTULA NEEDLE EUDAMED
- Device Name
- A.V. FISTULA NEEDLE SET EUDAMED
- Model / Reference
- 530-AGAM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04806538161390 EUDAMED
- Basic UDI-DI
- 480653816001CK EUDAMED
- EMDN Code
- F020101 ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE 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
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bionic Fistula Needle by Jms Healthcare Phl, 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 | 480653816001CK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jms Healthcare Phl, Inc
- EUDAMED SRN
- PH-MF-000024060
- Authorised Representative
- Bionic Medizintechnik GmbH DE-AR-000012049
Sources (1)
- EUDAMED 86d9c7a7-a798-4da8-a186-c1be04c9b75b 61 fields · synced Aug 1, 2026