Mendec V FILL ASC0000
by Tecres
Ref ASC0000
Mendec V FILL ASC0000 is a Class I device made by Tecres, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 80314970613P5) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 08031497001456), active as of 23 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 |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number80314970613P5 08031497001456 | Date28 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08031497001456 | Date23 Sep 2022 | StatusListed |
Official records
- EUDAMED public site 80314970613P5
- AccessGUDID record 08031497001456
Across registries
- EUDAMED Basic UDI-DI 80314970613P5 registered 28 Sep 2026 Active
- FDA GUDID UDI-DI 08031497001456 listed 23 Sep 2022 Listed
Timeline
- Listed FDA GUDID 08031497001456
- Registered EUDAMED 80314970613P5
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Mendec V FILL
- Generic name
- Orthopaedic cement preparation/delivery kit
- Model / reference
- ASC0000
- Primary DI / UDI-DI
- 08031497001456
- Basic UDI-DI
- 80314970613P5
- FDA product code
- HXK
- EMDN code
- K010399 Spinal endotherapy devices - other
- GMDN term
- Orthopaedic cement preparation/delivery kit
- Device class
- Class I
- Regulation number
- 888.4540
- EU registration type
- Standard device
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under SPINAL ENDOTHERAPY DEVICES.
- Dilator 15-2302 by ELLIQUENCE LLC
- Kyverment® JMSPACE100 by Joimax GmbH
- Muscle Dissector 15-2310 by ELLIQUENCE LLC
- 28761KB by Karl Storz SE & CO. KG
- MEDINAUT Plus Kyphoplasty System PIBE-15 by IMEDICOM CO., LTD.
- MEDINAUT-Ix ICD-CA1 by IMEDICOM CO., LTD.
- Synflate Vertebral Balloon Small Medium Large 03.804.702S by Synthes GmbH