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JMS SysLoc Safety A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref 862-1613
Identity
- Trade Name
- JMS SysLoc Safety A.V. Fistula Needle Set EUDAMED
- Device Name
- SYSLOC AVF EUDAMED
- Model / Reference
- 862-1613 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58888483004510 EUDAMED
- Basic UDI-DI
- B-58888483004510 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES 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
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
JMS SysLoc Safety 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-58888483004510 | 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 fadfc79a-0dc3-4145-8301-d88d0345d547 61 fields · synced Jun 18, 2026