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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

1306997 — Class I MDR by Medica Europe B.V.

MD Atlas
Medica Europe B.V.

EUDAMED last updated this device on Mar 1, 2023

1306997

8710685TF05001002QX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medica Europe B.V.
UDI-DI code: 08710685111091
Reference / catalog number: 1306997

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View device family (Basic UDI)

Manufacturer information

Organization name: Medica Europe B.V.
SRN: NL-MF-000000118
Manufacturer status: Active

Related devices

13037608710685TF05001002QXOn the market 13076878710685TF05001002QXOn the market 108396AA8710685TF05001001QVOn the market 13078178710685TF05001002QXOn the market 1303112 8710685TF05001002QXOn 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

2 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 2 countries total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market
Cyprus		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08710685111091
Basic UDI-DI: 8710685TF05001002QX
Reference / catalog number: 1306997
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)08710685111091

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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.

T020102SPECIALISTIC SURGERY DRAPES

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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