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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

11513EG — Class I MDR by Medica Europe B.V.

MD Atlas
Medica Europe B.V.

EUDAMED last updated this device on Jan 11, 2023

11513EG

8710685TF05001001QV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medica Europe B.V.
UDI-DI code: 08710685061334
Reference / catalog number: 11513EG

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View device family (Basic UDI)

Manufacturer information

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

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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
Belgium		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08710685061334
Basic UDI-DI: 8710685TF05001001QV
Reference / catalog number: 11513EG
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)08710685061334

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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.

T020402REINFORCED SURGICAL GOWNS

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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