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Medisure Coated Examination gown
EUDAMEDClass I (EU MDR)
Ref EDHA41007 Model LY-IG01
Identity
- Trade Name
- Medisure Coated Examination gown EUDAMED
- Device Name
- Isolation gown EUDAMED
- Model / Reference
- LY-IG01 EUDAMEDEDHA41007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975394401051 EUDAMED
- Basic UDI-DI
- 697539440LYIG00V8 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Medisure Coated Examination gown by Linye Health Tech(ningbo)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 | 697539440LYIG00V8 | Class I | Active |
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Manufacturer
- Manufacturer
- Linye Health Tech(ningbo)co., Ltd
- EUDAMED SRN
- CN-MF-000024232
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED c368fe1a-6755-44b9-a039-38b71daa018e 61 fields · synced Jun 18, 2026