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Allengers
EUDAMEDClass IIb (EU MDR)
Ref AGHPL/UM/HML (BLAZE-prime)/32Model BLAZE, BLAZE-prime
Identity
- Trade Name
- Allengers EUDAMED
- Device Name
- Holmium Medical Laser EUDAMED
- Model / Reference
- BLAZE, BLAZE-prime EUDAMEDAGHPL/UM/HML (BLAZE-prime)/32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906169420203 EUDAMED
- Basic UDI-DI
- 890616942HMLRS EUDAMED
- Direct Marketing DI
- 08906169420203 EUDAMED
- EMDN Code
- Z12011003 HOLMIUM SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Allengers by Allengers Global Healthcare Private Limited — Class IIb — 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 | 890616942HMLRS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Allengers Global Healthcare Private Limited
- EUDAMED SRN
- IN-MF-000039830
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (1)
- EUDAMED 818fe265-dd15-47ef-9d1e-09ca22a29b2a 61 fields · synced May 23, 2026