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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

Sana — Class I MDR by Intigena GmbH & Co.KG.

MD Atlas
Intigena GmbH & Co.KG.

EUDAMED last updated this device on Feb 16, 2022

Sana

0401320900001FL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Intigena GmbH & Co.KG.
UDI-DI code: 04013209000036
Reference / catalog number: 04013209000036

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Manufacturer information

Organization name: Intigena GmbH & Co.KG.
SRN: DE-MF-000004948
Manufacturer status: Active

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement		Still on market
XI		Still on market

Device identification

Trade name: Sana
UDI-DI code: 04013209000036
Basic UDI-DI: 0401320900001FL
Reference / catalog number: 04013209000036
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T99PROTECTIVE DEVICES AND AIDS FOR INCONTINENCE (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - 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

Related devices

040132090003950401320900002FNOn the market 040132090003880401320900002FNOn the market 040132090013920401320900001FLOn the market 040132090013850401320900001FLOn the market 040132090013780401320900001FLOn 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.