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Whicam Story3 wired
EUDAMEDFDA UDIClass I (EU MDR)
Ref Whicam Story3 wiredModel IC-WHW61
Identity
- Trade Name
- Whicam Story3 wired EUDAMEDWhicam Story3_wired FDA UDI
- Generic Name
- Surgical video camera FDA UDI
- Device Name
- Intraoral camera EUDAMEDFDA UDI
- Model / Reference
- IC-WHW61 EUDAMEDFDA UDIWhicam Story3 wired EUDAMED
- Description
- Intraoral camera FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800025400029 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000254WHW61LQ EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Z12119080 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Whicam Story3 wired by Good Doctors Co., Ltd. — 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 | 88000254WHW61LQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED d7e6c0a0-63df-4998-845a-4ec29eeb825e 61 fields · synced Jul 12, 2026
- FDA UDI 2cf3582d-54e7-49d6-9e88-51054abb77e1 33 fields · synced May 30, 2026