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Jisung
EUDAMEDClass I (EU MDR)
Ref JSA122AModel JSA111A 、JSA111B、 JSA111C、JSA112A、JSA112B、JSA112C、JSA113A、JSA113B、JSA113C、JSA121A 、JSA121B、 JSA121C、JSA122A、JSA122B、JSA122C
Identity
- Trade Name
- Jisung EUDAMED
- Device Name
- Underarm Crutches、Elbow crutches EUDAMED
- Model / Reference
- JSA111A 、JSA111B、 JSA111C、JSA112A、JSA112B、JSA112C、JSA113A、JSA113B、JSA113C、JSA121A 、JSA121B、 JSA121C、JSA122A、JSA122B、JSA122C EUDAMEDJSA122A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975576724121 EUDAMED
- Basic UDI-DI
- 697557672JSCRUTCH01CX EUDAMED
- EMDN Code
- Y12030601 ELBOW CRUTCHES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Jisung by Hebei Jisung Medical Equipment Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697557672JSCRUTCH01CX | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Jisung Medical Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000038654
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c3d61735-81bc-41da-8d53-de16afa2f5e8 61 fields · synced Jun 18, 2026