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Hot/Cold Pack
EUDAMEDClass I (EU MDR)
Ref cold packModel Hot/Cold Pack Heat pack cold pack heat/cold pack Instant cold pack
Identity
- Device Name
- Hot/Cold Pack EUDAMED
- Model / Reference
- Hot/Cold Pack Heat pack cold pack heat/cold pack Instant cold pack EUDAMEDcold pack EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975918770410 EUDAMED
- Basic UDI-DI
- 697591877HCP04SB 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
Hot/Cold Pack by Nanjing Ihome Comfort Co., Ltd — Class I — 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
- 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 | 697591877HCP04SB | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Ihome Comfort Co., Ltd
- EUDAMED SRN
- CN-MF-000037214
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED d70654d3-2a93-41c3-866c-6d5d11608f26 61 fields · synced Jun 18, 2026