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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

17.101 — Class I MDR by IDROFIL S.R.L

MD Atlas
IDROFIL S.R.L

EUDAMED last updated this device on Oct 6, 2023

17.101

8020255COT00MH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: IDROFIL S.R.L
UDI-DI code: 08020255000008
Reference / catalog number: 17.101

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View device family (Basic UDI)

Manufacturer information

Organization name: IDROFIL S.R.L
SRN: IT-MF-000034167
Manufacturer status: Active

Related devices

17.1008020255COT00MHOn the market 17.0508020255COT00MHOn the market 17.0808020255COT00MHOn the market REN018020255COT00MHOn the market EUROSPIN0018020255COT00MHOn 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.

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: 08020255000008
Basic UDI-DI: 8020255COT00MH
Reference / catalog number: 17.101
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08020255000008

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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.

M010101HYDROPHILIC COTTON

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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