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Hot Water Bag
EUDAMEDClass I (EU MDR)
Ref RubberModel Rubber,PVC,0.5L,1.0L,1.5L,1.75L,2.0L,2.2L,2.5L,3.0L,With cover etc
Identity
- Device Name
- HOT WATER BAG EUDAMED
- Model / Reference
- Rubber,PVC,0.5L,1.0L,1.5L,1.75L,2.0L,2.2L,2.5L,3.0L,With cover etc EUDAMEDRubber EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978186660810 EUDAMED
- Basic UDI-DI
- 697818666MKS006WD 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 Water Bag 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 THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- 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 | 697818666MKS006WD | 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 8df92af7-fc89-4368-8f08-89a8273f441f 61 fields · synced Jul 15, 2026