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VoirElite 4K 31.5"
EUDAMEDFDA UDIClass I (EU MDR)
Ref Fiber & SDI (JMASM00077)___ SDVoE & SDI (JMASM00081)___ HDMI & SDI (JMASM00082) Model Fiber & SD: JMASM00077; SDVoE & SDI: JMASM00081; HDMI & SDI: JMASM00082
Identity
- Trade Name
- VoirElite 4K 31.5" EUDAMEDVoirElite 4K 31.5 Surgical Display FDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- VoirElite 4K 31.5" EUDAMEDSurgical Display for Operating Room FDA UDI
- Model / Reference
- Fiber & SD: JMASM00077; SDVoE & SDI: JMASM00081; HDMI & SDI: JMASM00082 EUDAMEDFiber & SDI (JMASM00077)___ SDVoE & SDI (JMASM00081)___ HDMI & SDI (JMASM00082) EUDAMEDJMASM00077/81/82 FDA UDI
- Description
- Surgical Display for Operating Room FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008848925 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600088489JMASM000773B EUDAMED
- Direct Marketing DI
- 00860008848925 EUDAMED
- FDA Product Code
- FWC FDA UDI
- EMDN Code
- Z12020499 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER EUDAMED
- GMDN Term
- Image display unit, colour FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
VoirElite 4K 31.5" by JAM-Labs Corp. — 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 | 08600088489JMASM000773B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- JAM-Labs Corp.
- EUDAMED SRN
- US-MF-000038257
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 944c873b-9223-4a89-a823-241114311fb2 61 fields · synced Jul 28, 2026
- FDA UDI 1bb91051-3d86-4265-a500-3cf7e9f9e23f 33 fields · synced May 29, 2026