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Organization name
UDI-DI code
Reference / catalog number

AODI Small External Fixator… — Class IIb MDD by 41medical AG

MD Atlas
41medical AG

EUDAMED last updated this device on Jun 8, 2022

AODI Small External Fixator 0.8x1.2mm

B-07640185670013

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: 41medical AG
UDI-DI code: 07640185670013
Reference / catalog number: 100.126

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Manufacturer information

Organization name: 41medical AG
SRN: CH-MF-000016966
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Mar 9, 2021	May 26, 2024
Germany	Mar 9, 2021	May 26, 2024

Device identification

Trade name: AODI Small External Fixator 0.8x1.2mm
UDI-DI code: 07640185670013
Basic UDI-DI: B-07640185670013
Reference / catalog number: 100.126
Issuing entity: GS1

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: The AODI Small External Fixator is for temporary immobilization (a) in fractures of the metacarpal and phalanges of the hand for fracture stabilization and (b) in soft tissue surgery in the hand to reduce movement and thereby ensure undisturbed wound healing. The AODI Small External Fixator contains 4 steel wires with pre-as-sembled polyurethane blocks to fix to the bone and one carbon wire or one steel wire to connect the blocks to each other to a rigid con-struct.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P09120499EXTERNAL BONE FIXATION SYSTEMS - OTHER

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.