ViewHub
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ViewHub EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Video Processor EUDAMEDFDA UDI
- Model / Reference
- S13-T EUDAMEDFDA UDIS13 EUDAMEDFDA UDIS13, S13-T, S13-N, S13-S EUDAMED
- Description
- Video Processor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975339626686 EUDAMEDFDA UDI06975339626471 EUDAMED06975339626433 EUDAMED06975339626679 FDA UDI
- Basic UDI-DI
- 697533962002ML EUDAMED
- Direct Marketing DI
- 06975339626471 EUDAMED06975339626686 EUDAMED06975339626433 EUDAMED
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic video image processing unit
ViewHub by MacroLux Medical Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image processing unit.
- Pixa — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
- ILO — ILO electronic GmbH · Class I
- AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
- VIDEO PROCESSOR — PENTAX of America, Inc. · Class II
- Digital Video Processor — Hunan Vathin Medical Instrument Co., Ltd · Class II
- ILO — ILO electronic GmbH · Class I
- 3NT Video Console — 3nt Medical , Ltd. · Class II
- IMAGE1 X-LINK — Karl Storz GmbH & Co. KG · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MacroLux Medical Technology Co., Ltd.
Sources (5)
- FDA UDI d65a256f-41b9-4ba9-98bc-ccadddc32b74 33 fields · synced Sep 18, 2026
- FDA UDI b4a7e8bd-ca5c-4f1a-b1d6-42fa92672ba7 33 fields · synced May 30, 2026
- EUDAMED eef30140-cd1e-4b70-a935-375922d4286c 61 fields · synced Jul 22, 2026
- EUDAMED c5cd1669-face-4462-bf17-c791a785ac6b 61 fields · synced Jul 24, 2026
- EUDAMED c3b5ab24-397e-4b5c-b8aa-6c2215feda87 61 fields · synced Sep 18, 2026