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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

DFB-L-O-B12-035-R — Class III MDD by ASSUT EUROPE SPA

MD Atlas
ASSUT EUROPE SPA

EUDAMED last updated this device on Feb 27, 2026

DFB-L-O-B12-035-R

B-58033439420344

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ASSUT EUROPE SPA
UDI-DI code: 58033439420344
Reference / catalog number: DFB-L-O-B12-035-R

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View device family (Basic UDI)

Manufacturer information

Organization name: ASSUT EUROPE SPA
SRN: IT-MF-000018178
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

CSQ0013230524Supplemented
Quality management systemNotified body: 0373Expiry: Aug 7, 2028
CVD003124Issued
Technical documentationNotified body: 0373Expiry: Aug 7, 2028
CVD0030240124Supplemented
Technical documentationNotified body: 0373Expiry: Aug 7, 2028
CVD002023Issued
Technical documentationNotified body: 0373Expiry: Aug 7, 2028
CVD001423Issued
Technical documentationNotified body: 0373Expiry: Aug 7, 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 Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 58033439420344
Basic UDI-DI: B-58033439420344
Reference / catalog number: DFB-L-O-B12-035-R
Issuing entity: GS1

Classification

Risk category: Class III
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)58033439420344

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EMDN nomenclature code(s)

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

H0199SURGICAL SUTURES - 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

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