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Organization name
UDI-DI code
Reference / catalog number

Compression tights Dynaven Basic… — Class I MDR

MD Atlas
SIGVARIS SPÓŁKA AKCYJNA

EUDAMED last updated this device on Aug 26, 2024

Compression tights Dynaven Basic CCL 1

5906699DynavenBasicAT1RG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SIGVARIS SPÓŁKA AKCYJNA
UDI-DI code: 05906699076362
Reference / catalog number: 358023

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Manufacturer information

Organization name: SIGVARIS SPÓŁKA AKCYJNA
SRN: PL-MF-000004824
Manufacturer status: —

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 Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Sep 1, 2024	Still on market

Device identification

Trade name: Compression tights Dynaven Basic CCL 1
UDI-DI code: 05906699076362
Basic UDI-DI: 5906699DynavenBasicAT1RG
Reference / catalog number: 358023
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: Toe: open Length: long Colour: caramel Size: S
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

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M030405COMPRESSION STOCKINGS

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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Compression below knee Dynaven Basic CCL 1

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On the market

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