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JMS A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref 823-1534Ref 820-1509Ref 823-1535Ref 823-1633
Identity
- Trade Name
- JMS A.V. Fistula Needle Set EUDAMED
- Device Name
- AVF ROTATING HUB EUDAMEDAVF FIXED WING EUDAMED
- Model / Reference
- 823-1534 EUDAMED820-1509 EUDAMED823-1535 EUDAMED823-1633 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58888483006125 EUDAMED58888483000178 EUDAMED58888483006132 EUDAMED58888483003476 EUDAMED
- Basic UDI-DI
- B-58888483006125 EUDAMEDB-58888483000178 EUDAMEDB-58888483006132 EUDAMEDB-58888483003476 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 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-58888483006125 | 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 (4)
- EUDAMED 7d896484-c2f4-48d1-916d-d71e313a96d2 61 fields · synced Oct 6, 2026
- EUDAMED 95560963-f6d5-4bdc-a619-a9ac27f771c6 61 fields · synced May 18, 2026
- EUDAMED 76848c52-5176-4805-941d-7bdfc4344e7f 61 fields · synced May 18, 2026
- EUDAMED ea819f5e-0140-4ca6-9326-df3a469bbf3d 61 fields · synced May 18, 2026