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Wgs-100
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4162-01-15Model WGS-100Ref 4162-00-15Ref 4094-02-01Ref 3750-00-01Ref 4094-01-01Ref 4377-00-01
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 UDIWGS-100 Base Station FDA UDIWGS-100 Wireless Gating System FDA UDI
- Model / Reference
- WGS-100 EUDAMED4162-01-15 EUDAMED4162-00-15 EUDAMEDFDA UDI4094-02-01 EUDAMED4094-01-01 EUDAMEDFDA UDI3750-00-01 EUDAMED4377-00-01 EUDAMED3648-00-01 FDA UDI
- Description
- WGS-100 Charging Station FDA UDIWGS-100 Base Station FDA UDIWGS-100 Wireless Gating System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816396023550 EUDAMED00816396023253 EUDAMEDFDA UDI00816396023574 EUDAMED00816396023154 EUDAMEDFDA UDI00816396023147 EUDAMEDFDA UDI00816396023604 EUDAMED
- Basic UDI-DI
- 081639602WGS-100DD EUDAMED
- Direct Marketing DI
- 00816396023550 EUDAMED00816396023253 EUDAMED00816396023574 EUDAMED00816396023154 EUDAMED00816396023147 EUDAMED00816396023604 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
- Germany EUDAMEDItaly 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 UDIHeight — 7 Inch FDA UDIWidth — 5.5 Inch FDA UDIDepth — 2.5 Inch FDA UDIWeight — 1.7 Pound FDA UDIHeight — 26 Inch FDA UDIWidth — 18.5 Inch FDA UDIDepth — 6.75 Inch FDA UDIWeight — 3.17 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 |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
- EUDAMED SRN
- US-MF-000001164
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (9)
- EUDAMED 188243c1-ff7c-449d-9842-1f92c2d106f5 61 fields · synced Jul 20, 2026
- EUDAMED 86ffa8a6-ca4a-4e24-bebf-ed11fe037d41 61 fields · synced May 17, 2026
- EUDAMED 5d203ea7-0cb7-40ab-845e-c0dd5fb6a4df 61 fields · synced May 18, 2026
- FDA UDI 78fd8fd3-8c4c-42e9-a4e9-821bbbeb6059 35 fields · synced May 29, 2026
- FDA UDI b59d9d8e-9e23-4bb0-ae55-e7bb7b6e99e5 35 fields · synced May 30, 2026
- FDA UDI f65ae0ef-fed2-4ec1-b5d1-37f987719687 35 fields · synced May 30, 2026
- EUDAMED 615a7956-9a2a-4e31-8a06-48bfeb39fcea 61 fields · synced Jul 9, 2026
- EUDAMED 05ce7c44-fed6-4563-b1fa-3850c55a2915 61 fields · synced Jul 12, 2026
- EUDAMED f2aaa3ed-2ca8-4cd6-a7a5-9426f1efdd68 61 fields · synced Jul 20, 2026