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Plume SP MINI A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref AV17M15SGPModel 862-2700
Identity
- Trade Name
- Plume SP MINI A.V. Fistula Needle Set EUDAMED
- Device Name
- PLUME SP AVF EUDAMED
- Model / Reference
- 862-2700 EUDAMEDAV17M15SGP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58888483003131 EUDAMED
- Basic UDI-DI
- B-58888483003131 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Plume SP MINI 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-58888483003131 | 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 4604a4e3-cd22-475c-ac34-18349dde496e 61 fields · synced Jun 18, 2026