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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

Epi-Guard — Class I MDR by LiNA Medical AG

MD Atlas
LiNA Medical AG

EUDAMED last updated this device on Feb 24, 2026

Epi-Guard

57082653004-1SRB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LiNA Medical AG
UDI-DI code: 05708265015337
Reference / catalog number: 8170

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Manufacturer information

Organization name: LiNA Medical AG
SRN: CH-MF-000046832
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Denmark; available across 1 country total.

Placed on the market in Denmark; per-country availability dates not published.

Device identification

Trade name: Epi-Guard
UDI-DI code: 05708265015337
Basic UDI-DI: 57082653004-1SRB
Reference / catalog number: 8170
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: Achoring device for epidural catheters
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04010299FIXING DRESSINGS - 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

Certificate health across this manufacturer's portfolio.

TNP/MDR/0050/5851/2026Issued
Quality management systemNotified body: 2274Expiry: Feb 19, 2031