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Isolation gown
EUDAMEDClass I (EU MDR)
Ref EDHA4119XL/LY-IG08Model LY-IG01Ref EDHA41001/LY-IG02Ref EDHA4119M / LY-IG06Ref EDHA4119L/LY-IG07Ref EDHA41002 / LY-IG01
Identity
- Trade Name
- Isolation gown EUDAMED
- Device Name
- Isolation gown EUDAMED
- Model / Reference
- LY-IG01 EUDAMEDEDHA4119XL/LY-IG08 EUDAMEDEDHA41001/LY-IG02 EUDAMEDEDHA4119M / LY-IG06 EUDAMEDEDHA4119L/LY-IG07 EUDAMEDEDHA41002 / LY-IG01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975394401037 EUDAMED06975394400979 EUDAMED06975394401013 EUDAMED06975394401020 EUDAMED06975394400962 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
Isolation 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 (5)
- EUDAMED db9aaafd-c3ce-47f0-abe4-bfb95c4736ea 61 fields · synced Oct 9, 2026
- EUDAMED 086702bd-6e56-477d-bc98-ad4bd35d065d 61 fields · synced May 17, 2026
- EUDAMED 2ee95f71-67eb-497a-8653-b386f15b25a1 61 fields · synced May 17, 2026
- EUDAMED 9d50caef-3e60-4167-b623-3a255fa6072c 61 fields · synced May 18, 2026
- EUDAMED 4a4632b5-e42d-4bd4-91a2-8d247c8fc066 61 fields · synced May 19, 2026