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HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref A16R25B30SModel 862-1637
Identity
- Trade Name
- HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set EUDAMED
- Device Name
- SYSLOC AVF EUDAMED
- Model / Reference
- 862-1637 EUDAMEDA16R25B30S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-862-1637AZ EUDAMED
- Basic UDI-DI
- B-862-1637AZ 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-862-1637AZ | 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 8e23c52b-823d-4e01-b0f5-db2656d049c1 61 fields · synced Jun 18, 2026