2D Barcode Gun
by Instrumentation Laboratory Company United States EUDAMEDGUDID
Ref 00025000420
Product code CHLEMDN W0201040180
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number84269509157069C | Date15 Apr 2024 | StatusActive |
| United States | GUDID listing GUDID | Number08426950915706 | Date23 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- 2D Barcode Gun EUDAMEDWired Barcode Scanner (4k) (3500) (5k) GUDID
- Generic Name
- Barcode reader
- Model / Ref / Catalog
- 00025000420
- Primary DI / UDI-DI
- 08426950915706
- Basic UDI-DI
- 84269509157069C
- Direct Marketing DI
- 08426950915706
- FDA Product Code
- CHL
- EMDN Code
- W0201040180 Blood gas analysers - hardware accessories
- GMDN Term
- Barcode reader
- Device Class
- Class A EUDAMEDClass II GUDID
- Regulation Number
- 862.1120
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class A | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000035586
- Authorised representative
- Instrumentation Laboratory SpA IT-AR-000008169
Other devices from Instrumentation Laboratory Company
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED c42cc947-42f2-47b1-b4e9-731582294577
- FDA UDI 625c0f42-cddb-4f38-a1a8-1483c5c8b904