← Back to catalogue
HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref V16R20-15SModel 862-1633
Identity
- Trade Name
- HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set EUDAMED
- Device Name
- SYSLOC AVF EUDAMED
- Model / Reference
- 862-1633 EUDAMEDV16R20-15S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-862-1633AR EUDAMED
- Basic UDI-DI
- B-862-1633AR 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
HEMOTECH AVFHEMO Safety System 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-862-1633AR | 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 ac331758-0620-433b-bc45-f5752fcd280c 61 fields · synced Jun 19, 2026