Identity
- Trade Name
- WGS-100 EUDAMEDFDA UDI
- Generic Name
- MRI system synchronizer FDA UDI
- Device Name
- MR Wireless Gating System EUDAMEDWGS-100 Charging Station FDA UDI
- Model / Reference
- WGS-100 EUDAMED3750-01-01 EUDAMED3648-01-01 FDA UDI
- Description
- WGS-100 Charging Station FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816396023161 EUDAMEDFDA UDI
- Basic UDI-DI
- 081639602WGS-100DD EUDAMED
- Direct Marketing DI
- 00816396023161 EUDAMED
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- MRI system synchronizer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Italy 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 14 Inch FDA UDIWidth — 10 Inch FDA UDIDepth — 3.25 Inch FDA UDIWeight — 1.08 Pound FDA UDI
Wgs-100 by Ivy Biomedical Systems, Inc. — 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 | 081639602WGS-100DD | 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
- Ivy Biomedical Systems, Inc.
- EUDAMED SRN
- US-MF-000001164
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 310c189a-eeb6-423b-ac3a-87c6ca525dbf 61 fields · synced Jul 23, 2026
- FDA UDI 7914ba86-2e68-411a-b6f3-389ec0750570 35 fields · synced May 29, 2026