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Reusable H&C Gel Pack
EUDAMEDClass I (EU MDR)
Ref RED50001Model RED5000036SDVN-RR, RED5000124SDVN-RR
Identity
- Trade Name
- Reusable H&C Gel Pack EUDAMED
- Device Name
- Reusable H&C Gel PDQ EUDAMED
- Model / Reference
- RED5000036SDVN-RR, RED5000124SDVN-RR EUDAMEDRED50001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00064317500011 EUDAMED
- Basic UDI-DI
- 64317ravresuableDR EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Reusable H&C Gel Pack by Rapid Aid Vietnam Co., 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 | 64317ravresuableDR | Class I | Active |
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Manufacturer
- Manufacturer
- Rapid Aid Vietnam Co., Ltd
- EUDAMED SRN
- VN-MF-000033576
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8e295abe-c55d-4159-85ae-d9d005e5c3c3 61 fields · synced Jun 17, 2026