Identity
- Trade Name
- CorCam FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- CorCam EUDAMEDGamma Camera System FDA UDI
- Model / Reference
- 9COR2370-A04 EUDAMEDCorCam Gamma Camera System FDA UDI
- Description
- Gamma Camera System FDA UDI
Identifiers
- Catalog Number
- 9COR2370 FDA UDI
- Primary DI / UDI-DI
- 05711665002005 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05711665002005 EUDAMED
- 510(k) Number
- K011611 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11020104 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION EUDAMED
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Dimensions & Sizes
- Size
- Weight — 815 Kilogram FDA UDIHeight — 150 Centimeter FDA UDIDepth — 150 Centimeter FDA UDIWidth — 284 Centimeter FDA UDI
CorCam by Ddd-Diagnostic A/S — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05711665002005 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DDD-Diagnostic A/S
- EUDAMED SRN
- DK-MF-000009162
Sources (2)
- EUDAMED a3113026-44b5-4a5a-8fee-d7e3ec0e421a 61 fields · synced Jun 20, 2026
- FDA UDI e6ce3fbb-9d33-4293-95c2-426175e178ee 37 fields · synced May 30, 2026