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Cooling Patch
EUDAMEDClass I (EU MDR)
Ref KTMCP01Model KTMCP01,KTMCP02.KTMCP03, KTMCP04 Or Customization
Identity
- Device Name
- Cooling Patch EUDAMED
- Model / Reference
- KTMCP01,KTMCP02.KTMCP03, KTMCP04 Or Customization EUDAMEDKTMCP01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978914280242 EUDAMED
- Basic UDI-DI
- 697891428KTMCP001P7 EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) 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
Cooling Patch by Tianchang Kangtemei Protective Products 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 | 697891428KTMCP001P7 | Class I | Active |
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Manufacturer
- Manufacturer
- Tianchang Kangtemei Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000032474
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED cb153849-47ba-4d00-8381-506f89922086 61 fields · synced Jun 18, 2026