Identity
- Trade Name
- MUSCLE SUIT Soft-Light 2 M EUDAMED
- Device Name
- MEDIAID Assist Gear EUDAMED
- Model / Reference
- 307822 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582506231707 EUDAMED
- Basic UDI-DI
- 4946452SIGI01ZJ EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR 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
MUSCLE SUIT Soft-Light 2 M 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 | 4946452SIGI01ZJ | 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 c822c874-ee65-4eeb-b6e8-ef1aff2540cb 61 fields · synced Jul 8, 2026