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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

ROTO SILENTA 630 RS, 400V/50-60HZ… — Class IIa MDD

MD Atlas
Andreas Hettich GmbH

EUDAMED last updated this device on Sep 29, 2022

ROTO SILENTA 630 RS, 400V/50-60HZ (N2)

B-04050674031127

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Andreas Hettich GmbH
UDI-DI code: 04050674031127
Reference / catalog number: 5005-20

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Manufacturer information

Organization name: Andreas Hettich GmbH
SRN: DE-MF-000010680
Manufacturer status: Active

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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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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: ROTO SILENTA 630 RS, 400V/50-60HZ (N2)
UDI-DI code: 04050674031127
Basic UDI-DI: B-04050674031127
Reference / catalog number: 5005-20
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: —
Additional information URL: https://www.hettichlab.com/de/produkt/rotofix-32-a/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02069005REFRIGERATED CENTRIFUGES

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

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Software identification