Zetasafe
by Wuxi Exanovo Medical Instrument Co., Ltd.
Ref MC-50
Zetasafe (MC-50) is a Class I device made by Wuxi Exanovo Medical Instrument Co., Ltd., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-16970691004162), 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-16970691004162 16970691004162 | Date6 Nov 2026 | StatusActive |
Official records
- EUDAMED public site B-16970691004162
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Aneroid Sphygmomanometer
- Model / reference
- MC-50
- Primary DI / UDI-DI
- 16970691004162
- Basic UDI-DI
- B-16970691004162
- EMDN code
- C9006 Aneroid sphygmomanometers
- Device class
- Class I
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000021396
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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