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Kidney Care Patch
EUDAMEDClass I (EU MDR)
Ref Kidney Care PatchModel U01；U02；U03；U04；U05；U06；U07；U08；U09；U10；U11；U12；U13；U14；U15；U16；U17；U18；U19；U20
Identity
- Device Name
- Kidney Care Patch EUDAMED
- Model / Reference
- U01；U02；U03；U04；U05；U06；U07；U08；U09；U10；U11；U12；U13；U14；U15；U16；U17；U18；U19；U20 EUDAMEDKidney Care Patch EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972049413551 EUDAMED
- Basic UDI-DI
- 697204941KSHP01M8 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
Kidney Care 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 | 697204941KSHP01M8 | 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 34678782-2785-4ee8-b188-7cd06caaf3b7 61 fields · synced Jul 8, 2026