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Soft Ice/warm Bag
EUDAMEDClass I (EU MDR)
Ref 3978-GN-S-1Ref 3978-GN-L-1Ref 3978-GN-M-1
Identity
- Trade Name
- Soft Ice/warm Bag EUDAMED
- Device Name
- ICE/HOT PACK EUDAMED
- Model / Reference
- 3978-GN-S-1 EUDAMED3978-GN-L-1 EUDAMED3978-GN-M-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769156421 EUDAMED04711769156445 EUDAMED04711769156438 EUDAMED
- Basic UDI-DI
- 471986369CL109DV EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I 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
Soft Ice/warm Bag by OPPO Medical Corp. — 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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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 | 471986369CL109DV | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 6da88598-8cfd-4b4d-8126-1caa33be8151 61 fields · synced Jul 15, 2026
- EUDAMED c3360de0-9ff3-4cfa-86ff-34c49b7c03e8 61 fields · synced May 18, 2026
- EUDAMED a622c554-3c33-4419-a72b-3c1820ed0fb3 61 fields · synced May 18, 2026