Specht Upgrade
by IMT Integral Medizintechnik AG
Ref 800-09-001-IMT
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number76299990SpechtYG 07629999033979 | Date26 Mar 2025 | StatusActive |
| United States | GUDID listing GUDID | Number07629999033979 | Date23 Nov 2022 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Specht Upgrade EUDAMEDThe Woodpecker GUDID
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, pneumatic
- Device Name
- Woodpecker rasping machine surgical add-on tool
- Model / Reference
- 800-09-001-IMT EUDAMEDThe Woodpecker GUDID
- Primary DI / UDI-DI
- 07629999033979
- Basic UDI-DI
- 76299990SpechtYG
- FDA Product Code
- GET
- EMDN Code
- V9099 Various devices not included in other classes - other
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, pneumatic
- Device Class
- Class I
- Regulation Number
- 878.4820
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 800-09-001-IMT | The Woodpecker |
Manufacturer details
- EUDAMED SRN
- CH-MF-000037577
- Authorised representative
- Daniels Medizintechnik GmbH&Co.KG DE-AR-000004973
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Manufacturing Date: No