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Protective Gear
EUDAMEDClass I (EU MDR)
Ref IHCF1902Model IHCF1901/2/3/4/5/6/7/8/9/10/11/12/13/14/15/16/17/18Ref IHCF1901
Identity
- Device Name
- Protective Gear EUDAMED
- Model / Reference
- IHCF1901/2/3/4/5/6/7/8/9/10/11/12/13/14/15/16/17/18 EUDAMEDIHCF1902 EUDAMEDIHCF1901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975918771585 EUDAMED06975918771578 EUDAMED
- Basic UDI-DI
- 697591877PG16TR EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Protective Gear by Nanjing Ihome Comfort 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 | 697591877PG16TR | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Ihome Comfort Co., Ltd
- EUDAMED SRN
- CN-MF-000037214
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED c66550cb-918c-4e66-b3d8-77c55ec6ac80 61 fields · synced Oct 6, 2026
- EUDAMED 93fc96ef-62c0-46d9-a15e-592aa0c4b3ad 61 fields · synced May 16, 2026