Identity
- Trade Name
- JK Band (knee support) L EUDAMED
- Device Name
- ZAMST EUDAMED
- Model / Reference
- 671003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04946452068198 EUDAMED
- Basic UDI-DI
- 4946452SIG001VS EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
JK Band (knee support) L by Nippon Sigmax 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 | 4946452SIG001VS | Class I | Active |
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Manufacturer
- Manufacturer
- Nippon Sigmax Co., Ltd.
- EUDAMED SRN
- JP-MF-000016727
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a2c51903-6172-4c49-a64c-82a66a6a2795 61 fields · synced Jun 18, 2026