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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

GAMMAPRO HI-S — Class IIa MDR by GENERAL EQUIPMENT FOR…

MD Atlas
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.

EUDAMED last updated this device on Mar 13, 2023

GAMMAPRO HI-S

8437018413GAMMAPROBE7U

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
UDI-DI code: 08437018413096
Reference / catalog number: IC-1160

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Manufacturer information

Organization name: GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
SRN: ES-MF-000013779
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Consult user manual before use

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: GAMMAPRO HI-S
UDI-DI code: 08437018413096
Basic UDI-DI: 8437018413GAMMAPROBE7U
Reference / catalog number: IC-1160
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Wireless gamma probe
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 182 MU24
3.0 VDC - Single use lithium battery
255–266 MU50
40 MU50
255–266 MU50

EMDN nomenclature code(s)

Z11029001BETA/GAMMA DETECTORS

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

GAMMAPRO LAP8437018413GAMMAPROBE7UOn the market GAMMAPRO STD8437018413GAMMAPROBE7UOn the market MAMMI DR8437018413DEDICATEDPETJDOn the market MAMMI SR8437018413DEDICATEDPETJDOn the market SENTINELLA 1028437018413GAMMACAMERAN4On 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.