Identity
- Trade Name
- HANDCUFF EUDAMED
- Device Name
- HANDCUFF EUDAMED
- Model / Reference
- LY-HC01 EUDAMEDLY-HC01/EDHA10246 EUDAMEDLY-HC02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975394402010 EUDAMED06975394402027 EUDAMED
- Basic UDI-DI
- 697539440LYHC00UD EUDAMED
- EMDN Code
- M03030299 PROTECTION SYSTEMS - 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
Category: Cast/bandage waterproof bathing cover, reusable
Handcuff by Linye Health Tech(ningbo)co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cast/bandage waterproof bathing cover, reusable.
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- Seal-Tight — BROWNMED, INC. · Class I
- PLASTER OF PARIS BANDAGE — ANJI YAOHUI MEDICAL PRODUCTS CO., LTD. · Class I
- Transparent tape — Jiangsu Nanfang Medical Co., Ltd. · Class I
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 | 697539440LYHC00UD | 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 (2)
- EUDAMED d383bdbb-f010-4d1b-afc6-4b5f9df16125 61 fields · synced Oct 6, 2026
- EUDAMED 01c3e772-0e11-4913-a25a-094fcce592df 61 fields · synced May 18, 2026