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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

WOmed T-200 — Class IIb MDR by WOLF-Medizintechnik GmbH

MD Atlas
WOLF-Medizintechnik GmbH

EUDAMED last updated this device on Apr 30, 2025

WOmed T-200

++G205T300SERIESQC

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: WOLF-Medizintechnik GmbH
UDI-DI code: +G20542900
Reference / catalog number: 4290

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Manufacturer information

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

Critical warnings

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

CW011
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.
CW010
EUDAMED did not publish a description for this code.
CW265
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	Apr 1, 2025	Still on market

Device identification

Trade name: WOmed T-200
UDI-DI code: +G20542900
Basic UDI-DI: ++G205T300SERIESQC
Reference / catalog number: 4290
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 1
Additional product description: WOmed T-200 X-Ray therapy device with floor mounted column stand
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

Certificate health across this manufacturer's portfolio.

2025-MDR/QS-082Issued
Quality management systemNotified body: 2265Expiry: Nov 15, 2029
2024-MDR/QS-064Issued
Quality management systemNotified body: 2265Expiry: Nov 15, 2029
2023-MDR/QS-024Issued
Quality management systemNotified body: 2265Expiry: Aug 21, 2028