Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

9KID2275-B03 — Class IIa MDD by DDD-Diagnostic A/S

MD Atlas
DDD-Diagnostic A/S

EUDAMED last updated this device on Feb 8, 2022

9KID2275-B03

B-05711665022751

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: DDD-Diagnostic A/S
UDI-DI code: 05711665022751
Reference / catalog number: 9KID2275-B03

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Critical warnings

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

CW999
WARNING: Do not use the NephroCam 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 equipment 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 use the NephroCam system until you have received adequate and proper training in its safe and effective operation. If you are unsure about your ability to operate this equipment safely and effectively, DO NOT USE IT. Operation 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 NephroCam system for any purpose other than those for which it is intended. Operation of the NephroCam system for unintended purposes, or with incompatible equipment, could lead to fatal or other serious injury. It could also lead to clinical misdiagnosis.
CW999
Contra-indication: Do not use the system for patients who are restricted from having nuclear medicine studies (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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05711665022751
Basic UDI-DI: B-05711665022751
Reference / catalog number: 9KID2275-B03
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: NephroCam is a dedicated gamma camera system for functional imaging of the kidneys.
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)05711665022751

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

Z11020102FIXED STATION GAMMA CAMERAS WITH SINGLE HEAD - 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

Become a partner of MD Atlas

Related devices

9SOL2225-B03B-05711665022256On the market 9SYS2070-C05B-05711665003033On the market 9COR2370-A04B-05711665002005On the market 9SOL2210-B05B-05711665004009On the market 9PMS3060-A02B-05711665002012On the market

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.