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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

800135 — IVDR Class A IVDR by CENTOGENE GmbH

MD Atlas
CENTOGENE GmbH

EUDAMED last updated this device on Jan 13, 2023

800135

4260433590000018K

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: CENTOGENE GmbH
UDI-DI code: 14260433591350
Reference / catalog number: 800135

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Manufacturer information

Organization name: CENTOGENE GmbH
SRN: DE-MF-000020652
Manufacturer status: Active

Related devices

8001764260433590000018KOn the market 8001594260433590000018KOn the market 8001214260433590000018KOn the market 8001504260433590000018KOn the market 800171 4260433590000018KOn 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.

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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: 14260433591350
Basic UDI-DI: 4260433590000018K
Reference / catalog number: 800135
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0501010199VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
W0501010299CAPILLARY BLOOD COLLECTION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification