M-Wax
by Unisur Lifecare Private Limited
Ref S810
M-Wax (S810) is a Class IIb device made by Unisur Lifecare Private Limited, registered in EUDAMED on 17 Oct 2025 (Basic UDI-DI 890430012015ULSBW001XF) with CE/MDR certificate 2025-MDR/QS-011/A valid until 31 Jan 2030, active as of 25 Oct 2026.
Active
CE MDR
Valid until
31 Jan 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2025-MDR/QS-011/A | Date8 Jan 2026 | StatusActive |
Official records
- EUDAMED public site 890430012015ULSBW001XF
Certificates
- 2025-MDR/QS-011/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 8 Jan 2026
- Expires
- 31 Jan 2030
- 2025-MDR/TD-011/A Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 8 Jan 2026
- Expires
- 31 Jan 2030
Timeline
- Registered EUDAMED 890430012015ULSBW001XF
- Certificate issued EUDAMED 2025-MDR/QS-011/A
- Certificate issued EUDAMED 2025-MDR/TD-011/A
- Certificate expires EUDAMED 2025-MDR/QS-011/A
- Certificate expires EUDAMED 2025-MDR/TD-011/A
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade name
- M-WaxI Wax
- Device name
- Sterile Bonewax
- Model / reference
- S810
- Primary DI / UDI-DI
- 08904300102797, 08904300126274, 08904300144841, 08904300141390
- Basic UDI-DI
- 890430012015ULSBW001XF
- EMDN code
- M040506 Hemostatic waxes
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- FranceItaly
Manufacturer details
- EUDAMED SRN
- IN-MF-000008184
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Similar devices in this category
Other devices filed under HEMOSTATIC WAXES.