Identity
- Trade Name
- Sleep Patch EUDAMED
- Device Name
- Sleep Patch EUDAMED
- Model / Reference
- S01 EUDAMEDSleep Patch EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972049413346 EUDAMED
- Basic UDI-DI
- 697204941SP01K9 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Sleep Patch by Zhengzhou Langyi Biotech 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 | 697204941SP01K9 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhengzhou Langyi Biotech CO., LTD
- EUDAMED SRN
- CN-MF-000047344
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED b9410bd0-31e8-49ce-83c1-f46f038f2c03 61 fields · synced Jul 11, 2026