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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

4290 — Class IIb MDD by WOLF-Medizintechnik GmbH

MD Atlas
WOLF-Medizintechnik GmbH

EUDAMED last updated this device on Jun 14, 2022

4290

B-T-200_SN1220148CR

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: WOLF-Medizintechnik GmbH
UDI-DI code: D-T-200_SN1220148CR
Reference / catalog number: 4290

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Manufacturer information

Organization name: WOLF-Medizintechnik GmbH
SRN: DE-MF-000005165
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW016
EUDAMED did not publish a description for this code.
CW259
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	Jun 13, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-T-200_SN1220148CR
Basic UDI-DI: B-T-200_SN1220148CR
Reference / catalog number: 4290
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: T-200 konventionelle Röntgentherapie 200 kV, Bodenstativ
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11010301BRACHYTHERAPY RADIATION 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

7441B-T-105_SN1222040G4On the market 7441++G205T1056GOn the market 6571B-T-160_SN1220156JDOn the market 4290B-T-200_SN1220150CCOn the market 4290B-T-200_SN1220155CNOn 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.