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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

400-213MR — Class IIb MDR by MEDI-LINE S.r.l.

MD Atlas
MEDI-LINE S.r.l.

EUDAMED last updated this device on Jan 25, 2025

400-213MR

805511288K01020101M9

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDI-LINE S.r.l.
UDI-DI code: 08055112881643
Reference / catalog number: 400-213MR

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View device family (Basic UDI)

Manufacturer information

Organization name: MEDI-LINE S.r.l.
SRN: IT-MF-000019935
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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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: 08055112881643
Basic UDI-DI: 805511288K01020101M9
Reference / catalog number: 400-213MR
Issuing entity: GS1

Classification

Risk category: Class IIb
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055112881643

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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.

K01020101MINIMALLY INVASIVE SURGERY DISSECTORS, SINGLE-USE

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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Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

CSQ0003220524Supplemented
Quality management systemNotified body: 0373Expiry: Dec 27, 2027
CSQ000322Issued
Quality management systemNotified body: 0373Expiry: Dec 27, 2027