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Hot Patch
EUDAMEDClass I (EU MDR)
Ref Hot PatchModel HC01;HC02;HC03;HC04;HC05;HC06;HC07;HC08;HC09;HC10;HC11; HC12;HC13;HC14;HC15;HC16;HC17;HC18;HC19;HC20;HC21;HC22;HC23;HC24;HC25;HC26;HC27;HC28;HC29;HC30
Identity
- Device Name
- Hot Patch EUDAMED
- Model / Reference
- HC01;HC02;HC03;HC04;HC05;HC06;HC07;HC08;HC09;HC10;HC11; HC12;HC13;HC14;HC15;HC16;HC17;HC18;HC19;HC20;HC21;HC22;HC23;HC24;HC25;HC26;HC27;HC28;HC29;HC30 EUDAMEDHot Patch EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972049413391 EUDAMED
- Basic UDI-DI
- 697204941CPH01DN 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
Hot 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 | 697204941CPH01DN | 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 c28978f3-7583-4837-83ae-4fbeb776b756 61 fields · synced Jun 18, 2026