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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

Hyper.PACS V8 — Class IIb MDD by Telemis GmbH

MD Atlas
Telemis GmbH

EUDAMED last updated this device on Aug 8, 2022

Hyper.PACS V8

B-DE-MF-000018915GS

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Telemis GmbH
UDI-DI code: D-DE-MF-000018915GS
Reference / catalog number: Hyper.PACS V8

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Manufacturer information

Organization name: Telemis GmbH
SRN: DE-MF-000018915
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000018915GS
Basic UDI-DI: B-DE-MF-000018915GS
Reference / catalog number: Hyper.PACS V8
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.telemis.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z110603PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

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

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.