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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

Solo+ TTD — Class IIb MDD by AventaMed DAC

MD Atlas
AventaMed DAC

EUDAMED last updated this device on Feb 9, 2022

Solo+ TTD

B-05391528890101

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AventaMed DAC
UDI-DI code: 05391528890101
Reference / catalog number: 12115-200-000

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Manufacturer information

Organization name: AventaMed DAC
SRN: IE-MF-000004115
Manufacturer status: Active

Critical warnings

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

CW026
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Finland		Still on market
Portugal		Still on market

Device identification

Trade name: Solo+ TTD
UDI-DI code: 05391528890101
Basic UDI-DI: B-05391528890101
Reference / catalog number: 12115-200-000
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q03040101EAR DRAINAGE AND VENTILATION CATHETERS AND CANNULAS

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

Solo+ TTDB-05391528890156On 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.