Identity
- Trade Name
- Opti-Tip Master Pack EUDAMED
- Model / Reference
- NA EUDAMEDAC-00022910Be EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290117771799 EUDAMED
- Basic UDI-DI
- 729011777OPTTPK6 EUDAMED
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria 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
AC-00022910Be by Lumenis Be Ltd — 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 | 729011777OPTTPK6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lumenis Be LTD
- EUDAMED SRN
- IL-MF-000022063
- Authorised Representative
- Lumenis (Germany) GmbH DE-AR-000007699
Sources (2)
- EUDAMED d4fabcf8-6116-4caa-8595-614b73cf78f9 61 fields · synced Jun 20, 2026
- EUDAMED 946a6aa8-d783-4de9-a0d9-f86c4cfb428b 61 fields · synced Jun 20, 2026