← Back to catalogue
HEMO PHENIX A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref V15R20-30SP+Model 862-1535
Identity
- Trade Name
- HEMO PHENIX A.V. Fistula Needle Set EUDAMED
- Device Name
- HEMO PHENIX AVF EUDAMED
- Model / Reference
- 862-1535 EUDAMEDV15R20-30SP+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-862-1535AQ EUDAMED
- Basic UDI-DI
- B-862-1535AQ 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
HEMO PHENIX 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-862-1535AQ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- JMS Singapore Pte Ltd
- EUDAMED SRN
- SG-MF-000024704
- Authorised Representative
- Bionic Medizintechnik GmbH DE-AR-000012049
Sources (1)
- EUDAMED 2c33f3e4-d493-4e05-aaf0-0b8b81f6550c 61 fields · synced Jun 18, 2026