Identity
- Trade Name
- Opti-Tip Pack EUDAMED
- Model / Reference
- NA EUDAMEDKT-00036720Be EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290117771751 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
KT-00036720Be 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 47b8b4b0-1b1b-4172-a2ec-e8f09a6e7a6a 61 fields · synced Jun 19, 2026
- EUDAMED 432f74b0-9ac9-401e-8c25-1b9de46c58be 61 fields · synced Jun 19, 2026