Identity
- Trade Name
- BT Cool Easy EUDAMED
- Device Name
- Bleaching system EUDAMED
- Model / Reference
- BT Cool Plus EUDAMED04719883750280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883750280 EUDAMED
- Basic UDI-DI
- 471988375BleaheatlampBH EUDAMED
- Direct Marketing DI
- 04719883750280 EUDAMED
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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: Dental/surgical polymerization lamp
BT Cool Easy by Apoza Enterprise 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 | 471988375BleaheatlampBH | Class I | Active |
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Manufacturer
- Manufacturer
- Apoza Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000033094
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED bbafd5ec-c271-4fc1-8112-a7a4b3500809 61 fields · synced Jul 16, 2026