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Organization name
UDI-DI code
Reference / catalog number

R2 — Class I MDR by Comerge AG

MD Atlas
Comerge AG

Manufacturer information

Organization name: Comerge AG
SRN: CH-MF-000029069
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

ITH 2426703 1Supplemented
Quality management systemNotified body: 1936Expiry: Jul 23, 2028

Related devices

This device is not currently linked to any other device.

EUDAMED last updated this device on Aug 22, 2025

R2

7649994217013R25X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Comerge AG
UDI-DI code: 07649994217013
Reference / catalog number: R2

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Manufacturer information

Organization name: Comerge AG
SRN: CH-MF-000029069
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 07649994217013
Basic UDI-DI: 7649994217013R25X
Reference / catalog number: R2
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://neo-medical.com/wpfd_file/instructions-for-use-software-neo-advise-english/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11069001BIOIMAGING PROCESSORS

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

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

ITH 2426703 1Supplemented
Quality management systemNotified body: 1936Expiry: Jul 23, 2028