Identity
- Trade Name
- AnyCheck FDA UDI
- Generic Name
- Dental implant stability resonance frequency analysis unit FDA UDI
- Device Name
- Anycheck EUDAMEDAnyCheck IMT-100 FDA UDI
- Model / Reference
- IMT-100 EUDAMEDFDA UDI
- Description
- AnyCheck IMT-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038700000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800038700000 EUDAMED
- 510(k) Number
- K180953 FDA UDI
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- V030204 IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Dental implant stability resonance frequency analysis unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Spain 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Anycheck by Dms Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180953 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800038700000 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dms Co., Ltd.
- EUDAMED SRN
- KR-MF-000016967
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (3)
- EUDAMED 8a113678-8446-4b3a-9a08-efa99e35bb8d 61 fields · synced Jul 18, 2026
- FDA UDI afa48239-b7b3-4b2b-8ec1-d86746f6ab98 34 fields · synced May 30, 2026
- FDA 510(k) K180953 1 fields · synced May 18, 2026