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Warming and Cooling Therapy
EUDAMEDClass IIa (EU MDR)
Ref TP1000 & 2000-1 & 2000-2
Identity
- Device Name
- Warming and Cooling Therapy EUDAMED
- Model / Reference
- TP1000 & 2000-1 & 2000-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973181641765 EUDAMED
- Basic UDI-DI
- B-06973181641765 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
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Warming and Cooling Therapy by Dongguan Kaiser Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973181641765 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan Kaiser Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000006968
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 2f3886d3-57ba-45fa-85bf-db0e053fdcd9 61 fields · synced Jun 18, 2026