Identity
- Trade Name
- AccuGrid FDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- AccuGrid EUDAMEDDisposable Specimen Radiography System with Localizing Grid, 5.65" radiolucent grid FDA UDI
- Model / Reference
- 302 EUDAMEDFDA UDI
- Description
- Disposable Specimen Radiography System with Localizing Grid, 5.65" radiolucent grid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815137020193 EUDAMEDFDA UDI
- Basic UDI-DI
- 00815137020193BE EUDAMED
- Unit of Use DI
- 10815137020190 EUDAMED
- FDA Product Code
- NNI FDA UDI
- EMDN Code
- W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AccuGrid by Beekley Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 00815137020193BE | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Beekley Corporation
- EUDAMED SRN
- US-MF-000007055
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 35c6cd3e-4cea-4cdd-9405-214cf3d5af1e 61 fields · synced Jul 30, 2026
- FDA UDI d57a1746-3e49-4d44-a4c0-0079e3ae9fa9 33 fields · synced May 30, 2026