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Medical Hot And Cooling Gel Patch
EUDAMEDClass I (EU MDR)
Ref JI-201Model JI-201,JI-202,JI203,JI-204,JI-205,JI-206,JI-207,JI-208, 30X60MM,40X90MM,60X70MM,70X100MM 50X120MM or Customized size
Identity
- Device Name
- MEDICAL HOT AND COOLING GEL PATCH EUDAMED
- Model / Reference
- JI-201,JI-202,JI203,JI-204,JI-205,JI-206,JI-207,JI-208, 30X60MM,40X90MM,60X70MM,70X100MM 50X120MM or Customized size EUDAMEDJI-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978186661619 EUDAMED
- Basic UDI-DI
- 697818666MKS013WA EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES 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
Category: Hot/cold therapy pack, reusable
Medical Hot And Cooling Gel Patch by Zhengzhou Medcons Import&Export Trading Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
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- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
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- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology 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 | 697818666MKS013WA | Class I | Active |
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Manufacturer
- Manufacturer
- Zhengzhou Medcons Import&Export Trading Co., Ltd
- EUDAMED SRN
- CN-MF-000045994
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c5735236-126b-40c2-bbe2-828f85845270 61 fields · synced Sep 17, 2026