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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

Tear — Class I MDR by Care Design I/S

MD Atlas
Care Design I/S

EUDAMED last updated this device on Feb 21, 2026

Tear

571597400001345

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Care Design I/S
UDI-DI code: 05715974005771
Reference / catalog number: 801-Hvid-XXXL

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Manufacturer information

Organization name: Care Design I/S
SRN: DK-MF-000004848
Manufacturer status: Active

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement		Still on market

Device identification

Trade name: Tear
UDI-DI code: 05715974005771
Basic UDI-DI: 571597400001345
Reference / catalog number: 801-Hvid-XXXL
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: Tear
Additional information URL: https://www.caredesign.dk/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y090399CLOTHES, FOOTWEAR AND COVERS FOR PROSTHESES - OTHER

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.