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Plume SP MINI A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref A15M30SGPModel 862-1504Ref V16L15SGPModel 862-1602Ref V15L30SGPModel 862-1500Ref A15L30SGPModel 862-1501Ref A15L15SGPModel 862-1503Ref A16L30SGPModel 862-1601Ref V17L30SGPModel 862-1706Ref A17M30SGPModel 862-1703Ref A16M30SGPModel 862-1604Ref V15L15SGPModel 862-1502Ref V17M30SGPModel 862-1704Ref V16L30SGPModel 862-1600
Identity
- Trade Name
- Plume SP MINI A.V. Fistula Needle Set EUDAMED
- Device Name
- PLUME SP AVF EUDAMED
- Model / Reference
- 862-1504 EUDAMEDA15M30SGP EUDAMED862-1602 EUDAMEDV16L15SGP EUDAMED862-1500 EUDAMEDV15L30SGP EUDAMED862-1501 EUDAMEDA15L30SGP EUDAMED862-1503 EUDAMEDA15L15SGP EUDAMED862-1601 EUDAMEDA16L30SGP EUDAMED862-1706 EUDAMEDV17L30SGP EUDAMED862-1703 EUDAMEDA17M30SGP EUDAMED862-1604 EUDAMEDA16M30SGP EUDAMED862-1502 EUDAMEDV15L15SGP EUDAMED862-1704 EUDAMEDV17M30SGP EUDAMED862-1600 EUDAMEDV16L30SGP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58888483003032 EUDAMED58888483003056 EUDAMED58888483003155 EUDAMED58888483003162 EUDAMED58888483003025 EUDAMED58888483003186 EUDAMED58888483003247 EUDAMED58888483003094 EUDAMED58888483003070 EUDAMED58888483003018 EUDAMED58888483003100 EUDAMED58888483003179 EUDAMED
- Basic UDI-DI
- B-58888483003032 EUDAMEDB-58888483003056 EUDAMEDB-58888483003155 EUDAMEDB-58888483003162 EUDAMEDB-58888483003025 EUDAMEDB-58888483003186 EUDAMEDB-58888483003247 EUDAMEDB-58888483003094 EUDAMEDB-58888483003070 EUDAMEDB-58888483003018 EUDAMEDB-58888483003100 EUDAMEDB-58888483003179 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-58888483003032 | 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 (12)
- EUDAMED 8e621f71-683d-435b-adf4-5d748ff902d0 61 fields · synced Oct 6, 2026
- EUDAMED ba174d66-7014-43a6-8dd3-6dcba07a8beb 61 fields · synced May 17, 2026
- EUDAMED 4301d12b-6128-4726-a5e6-38f5395d96e3 61 fields · synced May 17, 2026
- EUDAMED f035fccf-3370-4183-aee0-168f8d12152d 61 fields · synced May 17, 2026
- EUDAMED abf5642e-07e9-4e54-a65e-b87b0158bf1f 61 fields · synced May 17, 2026
- EUDAMED 7b27dc82-59e5-4c75-be53-e5475397052f 61 fields · synced May 18, 2026
- EUDAMED cb122af4-46cf-47a3-a95d-e38043c46145 61 fields · synced May 18, 2026
- EUDAMED 7ccaeec6-9319-4ff6-8a87-00fce53b9fcb 61 fields · synced May 18, 2026
- EUDAMED 6ff16f60-d99c-4dc5-bbed-0be64a87d7a5 61 fields · synced May 18, 2026
- EUDAMED d4d5e9c2-40dc-486a-a85b-663e5288707d 61 fields · synced May 18, 2026
- EUDAMED 1fca1efb-9cfe-4905-a799-f5f2c9d47fa1 61 fields · synced May 19, 2026
- EUDAMED c40c0030-4350-4987-b643-e286299a58c2 61 fields · synced May 19, 2026