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JMS SysLoc Safety A.V. Fistula Needle Set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 862-1510510(k) K030479
Identity
- Trade Name
- JMS SysLoc Safety A.V. Fistula Needle Set EUDAMED
- Device Name
- SYSLOC AVF EUDAMED
- Model / Reference
- 862-1510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58888483004459 EUDAMED
- Basic UDI-DI
- B-58888483004459 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 — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030479 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-58888483004459 | Class IIa | Active |
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Manufacturer
- Manufacturer
- JMS Singapore Pte Ltd
- EUDAMED SRN
- SG-MF-000024704
- FDA Applicant
- Jms North America Corp.
- Authorised Representative
- Bionic Medizintechnik GmbH DE-AR-000012049
Sources (2)
- EUDAMED 96247fa7-70a0-4695-8990-297fbf3adf3c 85 fields · synced Jun 18, 2026
- FDA 510(k) K030479 1 fields · synced May 18, 2026