ACL200W
Ref ACL200WModel Accoson Examination Light
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
ACL200W is a Class I medical device designed for the non-invasive measurement of body temperature in adults. This examination light features a high-intensity LED bulb, adjustable brightness, and a comfortable ergonomic design. The device is also equipped with a USB rechargeable battery and can be used in various settings, including hospitals and clinics.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506048527GMACCACLL3 05060485270942 | Date26 May 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Accoson Examination Light, ACL200W
- Primary DI / UDI-DI
- 05060485270942
- Basic UDI-DI
- 506048527GMACCACLL3
- EMDN Code
- Z129004 Light sources
- Device Class
- Class I
- EU market of registration
- Malta
Manufacturer details
- EUDAMED SRN
- GB-MF-000020565
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from G.M. Instruments Ltd.
Properties
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