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Heat pack
EUDAMEDClass IIa (EU MDR)
Ref General type（01）Model General type(01)Ref Shoulder Neck type (02)Model Shoulder Neck type（02）
Identity
- Trade Name
- Heat pack EUDAMED
- Device Name
- Apply to the skin EUDAMED
- Model / Reference
- General type(01) EUDAMEDGeneral type（01） EUDAMEDShoulder Neck type（02） EUDAMEDShoulder Neck type (02) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950057910255 EUDAMED06950057910682 EUDAMED
- Basic UDI-DI
- 695005799101HB EUDAMED695005799102HD EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Heat pack by Jiangsu Meilan Medical Devices Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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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 | 695005799101HB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Meilan Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007952
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED b9cd717f-a192-4ef5-add9-2c1923b77b2e 61 fields · synced Jul 29, 2026
- EUDAMED dcf93eab-c377-4ee6-a81c-f408de3bef69 61 fields · synced May 18, 2026