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HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref V16R25-15SModel 862-1638
Identity
- Trade Name
- HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set EUDAMED
- Device Name
- SYSLOC AVF EUDAMED
- Model / Reference
- 862-1638 EUDAMEDV16R25-15S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-862-1638B3 EUDAMED
- Basic UDI-DI
- B-862-1638B3 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set by Jms Singapore Pte Ltd — 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-862-1638B3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- JMS Singapore Pte Ltd
- EUDAMED SRN
- SG-MF-000024704
- Authorised Representative
- Bionic Medizintechnik GmbH DE-AR-000012049
Sources (1)
- EUDAMED 01f6c8fa-92a5-4053-91f6-fc74300a81b2 61 fields · synced Jun 19, 2026