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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

9COR2370-A04 — Class IIa MDD by DDD-Diagnostic A/S

MD Atlas
DDD-Diagnostic A/S

EUDAMED last updated this device on Feb 17, 2022

9COR2370-A04

B-05711665002005

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: DDD-Diagnostic A/S
UDI-DI code: 05711665002005
Reference / catalog number: 9COR2370-A04

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Manufacturer information

Organization name: DDD-Diagnostic A/S
SRN: DK-MF-000009162
Manufacturer status: Active

Critical warnings

7 warnings recorded — scroll inside the panel to see all entries.

CW999
Contra-indication: Do not use the system for patients who are restricted from having a nuclear medicine procedure (according to either the referring physician or the radiologist).
CW999
Contra-indication: Also, operators should follow the guidelines and contraindications contained in the radiopharmaceutical package insert.
CW999
WARNING: Do not use the CorCam system for any application until you are sure that the Image Performance Quality Assurance has been satisfactorily completed, and that the general maintenance program is up to date. If any part of the equip-ment or system is known (or suspected) to be operating improperly or wrongly-adjusted, DO NOT USE the system until a repair has been made.
CW999
WARNING: Do not operate the CorCam system until you have read, understood and know all the safety information, safety procedures and emergency proce-dures contained in this Safety section. Operation of the CorCam system without a proper awareness of how to use it safely could lead to fatal or other serious personal injury.
CW999
WARNING: Do not operate the CorCam system until you have received adequate and proper training in its safe and effective operation. If you are unsure of your ability to operate this equipment safely and effectively DO NOT USE IT. Oper-ation of this equipment without proper and adequate training could lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis.
CW999
WARNING: Do not use the CorCam system for any purpose other than those for which it is intended. Operation of the CorCam system for unintended purposes, or with incompatible equipment, could lead to fatal or other serious injury. It could also lead to clinical misdiagnosis.
CW999
WARNING: Never attempt to remove, modify, override or forcibly move any safety de-vice on the equipment. Interfering with safety devices could lead to fatal or other serious personal injury.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05711665002005
Basic UDI-DI: B-05711665002005
Reference / catalog number: 9COR2370-A04
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CorCam is a dedicated gamma camera system for functional imaging of the heart.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05711665002005

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11020104FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.