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Rexicare Ice/Hot Bag
EUDAMEDClass I (EU MDR)
Ref RESB3006Model RESB3006-01/02/03/07/11/12/MX01 RESB3009-01/02/03/07/11/12/MX01 RESB3011-01/02/03/07/11/12/MX01
Identity
- Device Name
- REXICARE ICE/HOT BAG EUDAMED
- Model / Reference
- RESB3006-01/02/03/07/11/12/MX01 RESB3009-01/02/03/07/11/12/MX01 RESB3011-01/02/03/07/11/12/MX01 EUDAMEDRESB3006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710970381806 EUDAMED
- Basic UDI-DI
- 471097038RIHB01AW 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
Rexicare Ice/Hot Bag by R&R Medical Corporation 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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- 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 | 471097038RIHB01AW | Class I | Active |
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Manufacturer
- Manufacturer
- R&R Medical Corporation Ltd.
- EUDAMED SRN
- TW-MF-000029155
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2483c652-6628-4033-b015-bf14d51c5477 61 fields · synced Jun 19, 2026