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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

Needle Holder — Class IIa MDD by avateramedical GmbH

MD Atlas
avateramedical GmbH

EUDAMED last updated this device on Feb 8, 2023

Needle Holder

B-11504000005B5

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: avateramedical GmbH
UDI-DI code: D-11504000005B5
Reference / catalog number: 11504000005

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Manufacturer information

Organization name: avateramedical GmbH
SRN: DE-MF-000019824
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
EL		Still on market
Hungary		Still on market

Device identification

Trade name: Needle Holder
UDI-DI code: D-11504000005B5
Basic UDI-DI: B-11504000005B5
Reference / catalog number: 11504000005
Issuing entity: EUDAMED

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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12020185REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - CONSUMABLES

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

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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.