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KALAcool Spray Mint
EUDAMEDClass I (EU MDR)
Ref 5402354Model 350
by PRISMAN GmbH
Identity
- Trade Name
- KALAcool Spray Mint EUDAMED
- Device Name
- Kältespray CLASSIC EUDAMED
- Model / Reference
- 350 EUDAMED5402354 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797027974 EUDAMED
- Basic UDI-DI
- ++EPRM350A4E EUDAMED
- Direct Marketing DI
- 04064797027974 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
KALAcool Spray Mint by PRISMAN GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++EPRM350A4E | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED fb5f9e1b-09bf-4b6e-99ca-a8149a9fcf51 61 fields · synced Jun 19, 2026