Sharps Management
by GRI Medical & Electronic Technology Co., Ltd. China EUDAMEDGUDID
Ref 30-04037
Product code GABEMDN A018005
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69319181F018L4 | Date23 Jan 2025 | StatusActive |
| United States | GUDID listing GUDID | Number16931918173719 | Date27 Feb 2021 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Alleset
- Generic Name
- Sharp surgical instrument counting tray/pad, single-use
- Device Name
- Sharps Management
- Model / Reference
- 30-04037 EUDAMEDModel 30-04037 GUDID
- Primary DI / UDI-DI
- 16931918173719
- Basic UDI-DI
- 69319181F018L4
- FDA Product Code
- GAB
- EMDN Code
- A018005 Needle counting containers
- GMDN Term
- Sharp surgical instrument counting tray/pad, single-use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 30-04037 | Model 30-04037 |
Manufacturer details
- EUDAMED SRN
- CN-MF-000004203
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from GRI Medical & Electronic Technology Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- Sterile: No
- Implantable: No
- Reusable: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED d8cbfc12-50d3-4bd6-9717-048d33013a97
- FDA UDI 1fc466cc-7830-4e7c-aa8a-0a5d76dcdccb