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ULTRAMED A.V. FISTULA NEEDLE 16 G (Single)
EUDAMEDClass IIa (EU MDR)
Ref 9003-16/SModel ULTRAMED A.V. FISTULA NEEDLEModel ULTRAMED A.V. FISTULA NEEDLE 16 G (Single)
Identity
- Trade Name
- ULTRAMED A.V. FISTULA NEEDLE 16 G (Single) EUDAMED
- Device Name
- ULTRAMED A.V. FISTULA NEEDLE EUDAMED
- Model / Reference
- ULTRAMED A.V. FISTULA NEEDLE EUDAMED9003-16/S EUDAMEDULTRAMED A.V. FISTULA NEEDLE 16 G (Single) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004250378 EUDAMED
- Basic UDI-DI
- 622300425AVF9003RQ EUDAMEDB-06223004250378 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
ULTRAMED A.V. FISTULA NEEDLE 16 G (Single) by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDD, MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 622300425AVF9003RQ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 622300425AVF9003RQ | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 2462abf6-12f8-4958-9521-63cf17d82751 61 fields · synced Oct 9, 2026
- EUDAMED df66ca83-3e5f-4382-a13e-95e3462b8b14 61 fields · synced May 19, 2026