Identity
- Trade Name
- HugeMed EUDAMEDImage Processor FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Medical Image Processor EUDAMED
- Model / Reference
- HUV-02 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970462541516 EUDAMED06970462546207 FDA UDI
- Basic UDI-DI
- 69704625422017P EUDAMED
- Direct Marketing DI
- 06970462541516 EUDAMED
- 510(k) Number
- K222910 FDA UDIK231118 FDA UDIK231497 FDA UDIK232435 FDA UDIK240374 FDA UDIK241444 FDA UDI
- FDA Product Code
- EOQ FDA UDIFAJ FDA UDIFBN FDA UDIEOB FDA UDIFGB FDA UDIKQM FDA UDINTN FDA UDIFET FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI876.1500 FDA UDI874.4760 FDA UDI878.4160 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HugeMed by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class IIa — 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 | 69704625422017P | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 683f28f2-5e23-4f36-b688-d4393df615aa 61 fields · synced Jul 9, 2026
- FDA UDI 3e3f2fee-7646-4a6a-8da7-e32e7a6374cb 33 fields · synced May 30, 2026