Identity
- Trade Name
- Inspire EUDAMEDFDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral camera EUDAMEDLaser, Fluorescence Caries Detection FDA UDI
- Model / Reference
- IC-WHCD100 EUDAMEDFDA UDIInspire EUDAMED
- Description
- Laser, Fluorescence Caries Detection FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800025400135 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000254WHCD100E6 EUDAMED
- 510(k) Number
- K183471 FDA UDI
- FDA Product Code
- NBL FDA UDI
- EMDN Code
- Z12119080 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1745 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Inspire by Good Doctors Co., Ltd. — Class I — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183471 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 88000254WHCD100E6 | Class I | Active |
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Manufacturer
- Manufacturer
- Good Doctors Co., Ltd.
- EUDAMED SRN
- KR-MF-000035314
- Authorised Representative
- Good Doctors Germany GmbH DE-AR-000025472
Sources (3)
- EUDAMED 184117f7-b2b4-4cf7-be10-1e48b07e8daa 61 fields · synced Jul 11, 2026
- FDA UDI 93c15dd4-1af7-40d2-ae43-5a18b63c264a 34 fields · synced May 30, 2026
- FDA 510(k) K183471 1 fields · synced May 18, 2026