Am-5000
by Alltion (Guangxi) Instrument Co., Ltd.
Ref many
Am-5000 (many) is a general-purpose surgical microscope (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Alltion (Guangxi) Instrument Co., Ltd., registered in EUDAMED on 21 Apr 2026 (Basic UDI-DI 697044351AM500044) and listed in FDA GUDID since 9 Sep 2026 (UDI-DI 06970443510357), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06970443510357 | Date9 Sep 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number697044351AM500044 06970443510357 | Date21 Apr 2026 | StatusActive |
Official records
- EUDAMED public site 697044351AM500044
- AccessGUDID record 06970443510357
Across registries
- EUDAMED Basic UDI-DI 697044351AM500044 registered 21 Apr 2026 Active
- FDA GUDID UDI-DI 06970443510357 listed 9 Sep 2026 Listed
Timeline
- Registered EUDAMED 697044351AM500044
- Listed FDA GUDID 06970443510357
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Am-5000 EUDAMEDAlltion GUDID
- Generic name
- General-purpose surgical microscope
- Model / reference
- many EUDAMEDAM-5000 GUDID
- Primary DI / UDI-DI
- 06970443510357
- Basic UDI-DI
- 697044351AM500044
- Direct marketing DI
- 06970443510357
- FDA product code
- EPT
- EMDN code
- Z12011101 Operative microscopes
- GMDN term
- General-purpose surgical microscope
- Device class
- Class I
- Regulation number
- 878.4700
- EU registration type
- Standard device
- EU market of registration
- Bulgaria
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | many | AM-5000 |
Manufacturer details
- EUDAMED SRN
- CN-MF-000024670
- Authorised representative
- Obelis s.a. BE-AR-000000106
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