Identity
- Trade Name
- Osstell ISQ Probe EUDAMEDFDA UDI
- Generic Name
- Dental implant stability resonance frequency analysis unit FDA UDI
- Device Name
- Osstell ISQ Probe EUDAMEDISQ Measurement Instrument Accessory FDA UDI
- Model / Reference
- 100501 EUDAMEDOsstell ISQ Probe FDA UDI
- Description
- ISQ Measurement Instrument Accessory FDA UDI
Identifiers
- Catalog Number
- 100501 FDA UDI
- Primary DI / UDI-DI
- 09010522000731 EUDAMEDFDA UDI
- Basic UDI-DI
- 9010522ISQProbeKL EUDAMED
- Direct Marketing DI
- 09010522000731 EUDAMED
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant stability resonance frequency analysis unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Osstell ISQ Probe by Osstell AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 9010522ISQProbeKL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osstell AB
- EUDAMED SRN
- SE-MF-000002162
Sources (2)
- EUDAMED 7afbbbf1-a09f-407a-95e9-6ee457ab182c 61 fields · synced Jul 15, 2026
- FDA UDI e6599946-3bcc-4e6a-b9ce-12f3211118c4 34 fields · synced May 30, 2026