Identity
- Trade Name
- HAWK HD EUDAMEDHAWK FDA UDI
- Generic Name
- Intraoral camera FDA UDI
- Device Name
- Dental Camera EUDAMEDHighest resolution 1280 x 720 delivers precise, true-to-life images auto-focus system 15 advanced LED lights for the correct color representation FDA UDI
- Model / Reference
- HAWKHD EUDAMEDHD FDA UDI
- Description
- Highest resolution 1280 x 720 delivers precise, true-to-life images auto-focus system 15 advanced LED lights for the correct color representation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017900025 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000179INTRAORALCAMERAWW EUDAMED
- Direct Marketing DI
- 08800017900025 EUDAMED
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z11039010 PHOTO CAMERAS EUDAMED
- GMDN Term
- Intraoral camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hawk Hd by Dxm 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 | 88000179INTRAORALCAMERAWW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DXM Co., Ltd.
- EUDAMED SRN
- KR-MF-000016586
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 1ea3d39d-489f-4c1d-b5f7-05e25ec2c1a9 61 fields · synced Sep 18, 2026
- FDA UDI 16327fd1-ea3d-4061-9995-08e06e901385 33 fields · synced May 30, 2026