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Rexicare Soft Cold/Hot Gel Pack
EUDAMEDClass I (EU MDR)
Ref RESP7203Model RESP7203,RESP7201,RESP7221,RESP7212,RESP7215,RESP7216,RESP7217,RESP7241,RESP7242,RESP7243,RESP7244,RESP7245,RESP7301,RESP7302,RESP7503, etc
Identity
- Device Name
- REXICARE SOFT COLD/HOT GEL PACK EUDAMED
- Model / Reference
- RESP7203,RESP7201,RESP7221,RESP7212,RESP7215,RESP7216,RESP7217,RESP7241,RESP7242,RESP7243,RESP7244,RESP7245,RESP7301,RESP7302,RESP7503, etc EUDAMEDRESP7203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710970380007 EUDAMED
- Basic UDI-DI
- 471097038RSCHGP014R EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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: Device sterilization/disinfection container, reusable
Rexicare Soft Cold/Hot Gel Pack by R&R Medical Corporation Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471097038RSCHGP014R | 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 b0e463fc-843a-4a9f-a8a7-54eba7590848 61 fields · synced Jul 25, 2026