Identity
- Trade Name
- EDD-2 INVIVO Detector FDA UDI
- Generic Name
- Radiation electrometer FDA UDI
- Device Name
- EDD-2 3G-pSi Semiconductor detector, 4m cable FDA UDI
- Model / Reference
- 967-004 FDA UDI
- Description
- EDD-2 3G-pSi Semiconductor detector, 4m cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- EIBA9670040 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation electrometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation electrometer
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
Sources (1)
- FDA UDI a1db76fb-6d5d-44bc-ab5e-54f58d3222c5 34 fields · synced Jul 24, 2026