Identity
- Trade Name
- ZK-Protect (knee support) 2XL EUDAMED
- Device Name
- ZAMST EUDAMED
- Model / Reference
- 681705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04946452072201 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
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
ZK-Protect (knee support) 2XL 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 63aebdf6-dd7b-4e9e-9b2e-5d5c7d3a86a1 61 fields · synced Oct 6, 2026