Procedure Pack
by GRI Medical & Electronic Technology Co., Ltd.
Ref SYN2024Model VAS-04
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 | Number69319181F116L5 16931918122854 | Date9 Feb 2026 | StatusActive |
| United States | GUDID listing GUDID | Number16931918122854 | Date26 Apr 2024 | 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- Withdrawn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
- Syndeo Medical
- Generic Name
- General surgical procedure kit, non-medicated, single-use
- Device Name
- Procedure Pack
- Model / Reference
- VAS-04, SYN2024
- Primary DI / UDI-DI
- 16931918122854
- Basic UDI-DI
- 69319181F116L5
- FDA Product Code
- OEZ
- EMDN Code
- V0599 Clinical procedures kits not included in other classes - other
- GMDN Term
- General surgical procedure kit, non-medicated, single-use
- Device Class
- Class III EUDAMEDClass II GUDID
- Regulation Number
- 870.1200
- Medical Purpose
- The indications for use of Procedure packs will be determined by the physician based upon the specific type of procedure and products required to perform the procedure.
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class III | Class II |
Manufacturer details
- EUDAMED SRN
- CN-PR-000013744
Other devices from GRI Medical & Electronic Technology Co., Ltd.
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Properties
Other properties (9)
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No