Identity
- Trade Name
- OsteoProbe EUDAMED
- Device Name
- OsteoProbe EUDAMED
- Model / Reference
- OP-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860001719369 EUDAMED
- Basic UDI-DI
- 00860001719369AW EUDAMED
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OsteoProbe by Active Life Scientific, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250216 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | DEN210013 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221195 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 00860001719369AW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Active Life Scientific, Inc.
- EUDAMED SRN
- US-MF-000022740
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED a1555d1b-173a-4b19-a0e3-ac7681d2c2fa 61 fields · synced Jul 24, 2026
- FDA 510(k) K250216 1 fields · synced May 18, 2026