Identity
- Trade Name
- OLINDA/EXM FDA UDI
- Generic Name
- Nuclear medicine system workstation FDA UDI
- Device Name
- The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application. FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859873006035 FDA UDI
- FDA Product Code
- IYX FDA UDI
- GMDN Term
- Nuclear medicine system workstation FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1100 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nuclear medicine system workstation
Olinda/Exm by Hermes Medical Solutions AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Hermes Medical Solutions AB
Sources (1)
- FDA UDI 0f2c186c-a8d2-41df-a68e-6a9269eb745d 35 fields · synced Jun 1, 2026