Identity
- Trade Name
- HD 8Ch Wrist Array EUDAMEDDUNLEE SENTINELLE FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- GE Ortho Coil PMS EUDAMEDHD 8Ch Wrist Array FDA UDI
- Model / Reference
- 300007292751 EUDAMEDHD 8Ch Wrist Array FDA UDI
- Description
- HD 8Ch Wrist Array FDA UDI
Identifiers
- Catalog Number
- 300007292751 FDA UDI
- Primary DI / UDI-DI
- 00884838108905 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM904TF EUDAMED
- Direct Marketing DI
- 00884838108905 EUDAMED
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001,Z1105018002,Z1105018099 EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
HD 8Ch Wrist Array by Philips Medical Systems Nederland B.V. — Class IIa — 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 | 0884838BM904TF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 3b2ad46d-eb4e-49f3-8bd7-676072911a76 61 fields · synced Oct 6, 2026
- FDA UDI cf69cf3f-0c45-47c4-b86e-f42cc8e1805f 36 fields · synced May 30, 2026