PRIMA ENT -Motorized Fine Focus
by Labo America Inc. United States EUDAMED
Ref 6137000-100Model Prima,Prima Mu,Prima Swift,Stella,Stella N,Prima Lite EMDN Z12011101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number81017855ENTSURGICALDV | Date24 Sep 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Surgical (Operating) Microscopes
- Model / Reference
- Prima, Prima Mu, Prima Swift, Stella, Stella N, Prima Lite, 6137000-100
- Primary DI / UDI-DI
- 00810178550241
- Basic UDI-DI
- 81017855ENTSURGICALDV
- Direct Marketing DI
- 00810178550241
- EMDN Code
- Z12011101 Operative microscopes
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000044352
- Authorised representative
- Labomed Europe b.v. NL-AR-000022889
Other devices from Labo America Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 389814f5-4120-4651-99ea-0bb5fe06dba5