Identity
- Trade Name
- ORION RACK Assembly EUDAMEDORION RACK FDA UDI
- Generic Name
- Medical device integration rack FDA UDI
- Device Name
- ORION Rack Assembly EUDAMEDVideo Integration Control System FDA UDI
- Model / Reference
- JMKIT00004 EUDAMED1.0.0 FDA UDI
- Description
- Video Integration Control System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008848901 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600088489JMASM000893J EUDAMED
- Direct Marketing DI
- 00860008848901 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
- GMDN Term
- Medical device integration rack FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ORION RACK Assembly 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 | 08600088489JMASM000893J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- JAM-Labs Corp.
- EUDAMED SRN
- US-MF-000038257
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED ea1170e2-4262-4e90-b3a4-59080790952a 61 fields · synced Jun 18, 2026
- FDA UDI e3d188ce-5098-4f52-bc99-c48aff7e1f1d 34 fields · synced May 30, 2026