Identity
- Trade Name
- SIGNA PET/MR EUDAMEDNA FDA UDI
- Generic Name
- PET/MRI system FDA UDI
- Device Name
- SIGNA PET/MR EUDAMEDPETMR PGR Upgrade Kit, MP24 to MP30 FDA UDI
- Model / Reference
- SIGNA PET/MR EUDAMEDSIGNA PET MR FDA UDI
- Description
- PETMR PGR Upgrade Kit, MP24 to MP30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278729224 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00307H9 EUDAMED
- 510(k) Number
- K213709 FDA UDI
- FDA Product Code
- OUO FDA UDI
- EMDN Code
- Z11020701 MRI/PET SYSTEMS EUDAMED
- GMDN Term
- PET/MRI system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Signa Pet/Mr by GE Medical Systems, LLC — 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 | 8406821BUG00307H9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems LLC
- EUDAMED SRN
- US-MF-000001632
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED f507129e-70b7-41ec-af82-2efc5c7b1f1d 61 fields · synced Jul 19, 2026
- FDA UDI ce812fa9-eec0-419c-92a8-84846f3be072 34 fields · synced May 30, 2026