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Jisung
EUDAMEDClass I (EU MDR)
Ref JSA111CModel 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 EUDAMEDJSA111C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975576724022 EUDAMED
- Basic UDI-DI
- 697557672JSCRUTCH01CX EUDAMED
- EMDN Code
- Y120399 WALKING DEVICES, ONE-HANDED OPERATION - OTHER 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 2f7ff9c2-be72-482a-8dbe-e34f3ab08bd3 61 fields · synced Jun 19, 2026