Identity
- Trade Name
- WGS-100 EUDAMED
- Device Name
- MR Wireless Gating System EUDAMED
- Model / Reference
- WGS-100 EUDAMED4376-00-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816396023598 EUDAMED
- Basic UDI-DI
- 081639602WGS-100DD EUDAMED
- Direct Marketing DI
- 00816396023598 EUDAMED
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Wgs-100 by Ivy Biomedical Systems, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081639602WGS-100DD | Class I | Active |
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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 (1)
- EUDAMED 7c81f8c8-bfdf-4081-8d9c-8908ab013efb 61 fields · synced Jun 9, 2026