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Healthpoint(DIRECT TO SKIN HEAT PADS)
EUDAMEDClass IIa (EU MDR)
Ref 130*95MMModel General type(01)
Identity
- Trade Name
- Healthpoint(DIRECT TO SKIN HEAT PADS) EUDAMED
- Device Name
- Apply to the skin EUDAMED
- Model / Reference
- General type(01) EUDAMED130*95MM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950057903028 EUDAMED
- Basic UDI-DI
- 695005799101HB EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Healthpoint(DIRECT TO SKIN HEAT PADS) 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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- HotCold Pack reusable — Bevaplast B.V. · 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 (1)
- EUDAMED e1103008-90b5-4ac0-aa73-4d0ddaeb65cc 61 fields · synced Oct 6, 2026