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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

08032472028635 — Class III MDR by ABOCA S.P.A. SOCIETÀ…

MD Atlas
ABOCA S.P.A. SOCIETÀ AGRICOLA

EUDAMED last updated this device on Jul 19, 2024

08032472028635

8032472BIOANAby2AA

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ABOCA S.P.A. SOCIETÀ AGRICOLA
UDI-DI code: 08032472028635
Reference / catalog number: 08032472028635

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View device family (Basic UDI)

Manufacturer information

Organization name: ABOCA S.P.A. SOCIETÀ AGRICOLA
SRN: IT-MF-000029499
Manufacturer status: Active

Related devices

080324720390998032472NASALcw35ROn the market 080324720288958032472CUGOby22COn the market 080324720282918032472CUTOSax1G9On the market 080324720156048032472CUGOby22COn the market 080324720156118032472CUGOax122On the market

Certificates

Certificate health across this manufacturer's portfolio.

CVD002223Issued
Technical documentationNotified body: 0373Expiry: Mar 26, 2028
CSQ0009230223Supplemented
Quality management systemNotified body: 0373Expiry: Mar 26, 2028

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08032472028635
Basic UDI-DI: 8032472BIOANAby2AA
Reference / catalog number: 08032472028635
Issuing entity: GS1

Classification

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

Device details

Quantity: 14
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08032472028635

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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

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