Identity
- Trade Name
- VibraCool® Flex EUDAMED
- Device Name
- Buzzy® and VibraCool EUDAMED
- Model / Reference
- VC-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00856921003169 EUDAMED
- Basic UDI-DI
- 85692100BuzzyC2 EUDAMED
- Direct Marketing DI
- 00856921003169 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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: Device sterilization/disinfection container, reusable
VibraCool® Flex by Pain Care Labs — 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 | 85692100BuzzyC2 | Class I | Active |
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Manufacturer
- Manufacturer
- Pain Care Labs LLC
- EUDAMED SRN
- US-MF-000010505
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED 13f63022-8cb9-422a-9ddb-3ef3bd04a512 61 fields · synced Aug 2, 2026