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Hugemed
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8802BModel VL3R, VL3D, VL3REX, VL3DEX, VL4R, VL4D, VL4REX, VL4DEX, VL3N, VL4N, VLRM, VLDM, VL3H, VL3S, VLMCF, VL4CTRef 2003BRef SA01Ref 8801BRef 8800BRef VL4CTRef 1805BRef HY-45AModel HY-45A, HY-45B, HY-50A, HY-50BRef 2002BRef 1805-1BRef HY-50BRef 8000BModel HU30,HU30S,HU30MRef MS-8Ref Y-11-50Model Y-09-40, Y-09-50, Y-10-40, Y-10-50, Y-11-40, Y-11-50, Y-12-40, Y-12-50
Identity
- Trade Name
- Hugemed EUDAMEDImage Processor FDA UDISingle-use Ureteral Access Sheath FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDIUreteral introduction sheath FDA UDI
- Device Name
- Video Laryngoscope EUDAMEDSingle-use Collector EUDAMEDSingle-use Hysteroscope EUDAMEDSingle-Use Ureterorenoscope EUDAMEDMedical Image Processor EUDAMEDSingle-use Ureteral Access Sheath EUDAMED
- Model / Reference
- VL3R, VL3D, VL3REX, VL3DEX, VL4R, VL4D, VL4REX, VL4DEX, VL3N, VL4N, VLRM, VLDM, VL3H, VL3S, VLMCF, VL4CT EUDAMED8802B EUDAMED2003B EUDAMEDSA01 EUDAMED8801B EUDAMED8800B EUDAMEDVL4CT EUDAMED1805B EUDAMEDHY-45A, HY-45B, HY-50A, HY-50B EUDAMEDHY-45A EUDAMED2002B EUDAMED1805-1B EUDAMEDHY-50B EUDAMEDMS-8 EUDAMEDFDA UDIY-11-50 EUDAMEDFDA UDIHU30,HU30S,HU30M EUDAMED8000B EUDAMEDY-09-40, Y-09-50, Y-10-40, Y-10-50, Y-11-40, Y-11-50, Y-12-40, Y-12-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970462540007 EUDAMED06970462540175 EUDAMED06970462542605 EUDAMED06970462540014 EUDAMED06970462540052 EUDAMED06970462542490 EUDAMED06970462540076 EUDAMED06970462542735 EUDAMED06970462540021 EUDAMED06970462540083 EUDAMED06970462542766 EUDAMED06970462540892 EUDAMED06970462541523 EUDAMED06970462540069 EUDAMED06970462540922 EUDAMED06970462542681 EUDAMED06970462546191 FDA UDI06970462546795 FDA UDI
- Basic UDI-DI
- 69704625488009V EUDAMED697046254241184 EUDAMED69704625424017Z EUDAMED69704625480008M EUDAMED69704625422888V EUDAMED69704625424078D EUDAMED
- Direct Marketing DI
- 06970462540007 EUDAMED06970462540175 EUDAMED06970462540014 EUDAMED06970462540052 EUDAMED06970462542490 EUDAMED06970462540076 EUDAMED06970462540021 EUDAMED06970462540083 EUDAMED06970462541523 EUDAMED06970462540069 EUDAMED
- 510(k) Number
- K222910 FDA UDIK231118 FDA UDIK231497 FDA UDIK232435 FDA UDIK240374 FDA UDIK250695 FDA UDI
- FDA Product Code
- EOQ FDA UDIFAJ FDA UDIFBN FDA UDIEOB FDA UDIFGB FDA UDIFED FDA UDI
- EMDN Code
- Z12021004 VIDEO LARYNGOSCOPES EUDAMEDZ12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMEDZ12020712 VIDEO HYSTEROSCOPES EUDAMEDZ12020709 UTEROSCOPES EUDAMEDZ12020406 VIDEO PROCESSORS EUDAMEDU0280 URETERAL CATHETERS AND STENTS - ACCESSORIES EUDAMED
- GMDN Term
- Endoscopic video image processing unit FDA UDIUreteral introduction sheath FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI876.1500 FDA UDI874.4760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA 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 UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Hugemed by Shenzhen HugeMed Medical Technical Development 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 | 69704625488009V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (18)
- EUDAMED dde7e8cd-a5a4-4dd9-b78a-d3a8a9c9237b 61 fields · synced Jul 29, 2026
- EUDAMED f5106fee-cbc2-4a28-9018-1083be3d3a48 61 fields · synced May 16, 2026
- EUDAMED 23d4e88c-c75c-4692-9246-d1d77dd39bc8 61 fields · synced May 16, 2026
- EUDAMED 24967b0f-8181-4d89-b9a1-31d45ce331f2 61 fields · synced May 16, 2026
- EUDAMED 955765f7-4de4-4613-a6ea-caf784904d84 61 fields · synced May 16, 2026
- EUDAMED d50f6618-64c2-4978-bd21-f61e2590f88d 61 fields · synced May 17, 2026
- EUDAMED 446fd55e-4d61-47b7-9be5-2b9cf64595d3 61 fields · synced May 17, 2026
- EUDAMED 9b299c8e-00fb-4dfd-90e9-bf079902aa43 61 fields · synced May 17, 2026
- EUDAMED 5e26559b-7632-4673-bdc1-b898f0604147 61 fields · synced May 17, 2026
- EUDAMED 6477d77c-5b4d-4b6d-a151-804e5f358925 61 fields · synced May 17, 2026
- EUDAMED e8d09691-d9e8-48cc-9e97-5de8dad4907a 61 fields · synced May 18, 2026
- FDA UDI 721d7b29-06c6-4eb8-9b74-138da80bdd16 33 fields · synced May 29, 2026
- FDA UDI 4283bba2-360e-4cd0-9e5b-b2fdb574d3c1 33 fields · synced May 30, 2026
- EUDAMED 6aec7823-d33d-444e-94a9-36bc4c05a346 61 fields · synced Jul 8, 2026
- EUDAMED 6d4c417f-67d0-4066-bee6-adba3e80ae70 61 fields · synced Jul 9, 2026
- EUDAMED 1f2490d0-bea0-493b-9b4a-b49393b887d1 61 fields · synced Jul 10, 2026
- EUDAMED b96ce18e-e643-41b1-a7c1-acb5e25b97c0 61 fields · synced Jul 10, 2026
- EUDAMED 51cfed56-fbc3-4a5d-8e46-3a0121fb7e4a 61 fields · synced Jul 25, 2026