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Coolingbis 1.0
EUDAMEDClass IIb (EU MDR)
Ref APM10900.201Model SURTRON TOUCH HP 400
by LED SpA
Identity
- Trade Name
- COOLINGBIS 1.0 EUDAMED
- Device Name
- SURTRON TOUCH HP 400 EUDAMED
- Model / Reference
- SURTRON TOUCH HP 400 EUDAMEDAPM10900.201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033638325421 EUDAMED
- Basic UDI-DI
- 803363832HFS00144 EUDAMED
- Direct Marketing DI
- 08033638325421 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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: Foot-switch, electrical
Coolingbis 1.0 by Led Spa — Class IIb — 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 | 803363832HFS00144 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LED SpA
- EUDAMED SRN
- IT-MF-000012232
Sources (1)
- EUDAMED 8f94f669-c1bd-4054-87ae-d7cbfff7d9b3 61 fields · synced Jun 18, 2026