HR650 Applicator
Ref AS900210
HR650 Applicator (AS900210) is a Class IIb device made by Venus Concept Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00810060831397), active as of 7 Nov 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-00810060831397 00810060831397 | Date6 Nov 2026 | StatusActive |
Official records
- EUDAMED public site B-00810060831397
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- HR650 Applicator
- Model / reference
- AS900210
- Primary DI / UDI-DI
- 00810060831397
- Basic UDI-DI
- B-00810060831397
- EMDN code
- X0502 High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body, for skin resurfacing, tattoo or hair removal or other skin treatment – intense pulsed light
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- US-MF-000040223
- Authorised representative
- Obelis s.a. BE-AR-000000106
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