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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

Hollow Obturator — Class I MDR by Erbe Vision GmbH

MD Atlas
Erbe Vision GmbH

EUDAMED last updated this device on Jun 13, 2024

Hollow Obturator

426021465OBTURATORSA5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Erbe Vision GmbH
UDI-DI code: 04260214653355
Reference / catalog number: 20864-049

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Manufacturer information

Organization name: Erbe Vision GmbH
SRN: DE-MF-000010268
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.

CW133
"The devices are contraindicated for all the intended uses, other than the ones claimed by manufacturer. The devices are to be neither used in contact with central circulatory system nor with central nervous system. Do not use the devices if one condition is present: • Acute inflammation of the abdominal area • Urinary tract infection • Coagulation disorder"

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: Hollow Obturator
UDI-DI code: 04260214653355
Basic UDI-DI: 426021465OBTURATORSA5
Reference / catalog number: 20864-049
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Hollow obturator,centr.channel 5 CH, for guiding catheter
Additional information URL: https://register.erbe-med.com/productfinder/Marketingmaterialien/30864-031_ERBE_EN_Urethrotomy_System__D213735.pdf
Clinical sizes: 5 MU170

EMDN nomenclature code(s)

Z12020780GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES

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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