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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

3520-1 — Class I MDR by Asa Dental S.p.A.

MD Atlas
Asa Dental S.p.A.

EUDAMED last updated this device on May 9, 2023

3520-1

80557743950107J

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Asa Dental S.p.A.
UDI-DI code: 08050593907080
Reference / catalog number: 3520-1

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View device family (Basic UDI)

Manufacturer information

Organization name: Asa Dental S.p.A.
SRN: IT-MF-000010736
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030166-00Issued
Quality management systemNotified body: 0425Expiry: Dec 21, 2030

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08050593907080
Basic UDI-DI: 80557743950107J
Reference / catalog number: 3520-1
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: 840
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)08050593907080

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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.

Q019004DENTAL COTTON ROLLS

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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