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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

K816411 — Class I MDR by KARREL HEALTH SOLUTIONS…

MD Atlas
KARREL HEALTH SOLUTIONS SRL

EUDAMED last updated this device on May 20, 2026

K816411

805969385K816MMTKY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KARREL HEALTH SOLUTIONS SRL
UDI-DI code: 08059693850388
Reference / catalog number: K816411

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View device family (Basic UDI)

Manufacturer information

Organization name: KARREL HEALTH SOLUTIONS SRL
SRN: IT-MF-000028683
Manufacturer status: Active

Related devices

K816209G805969385K81620XXL9On the market K816209GX805969385K81620XXL9On the market K816419G805969385K81641XXLUOn the market K816419A3805969385K81641XXLUOn the market K816419GX805969385K81641XXLUOn 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

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08059693850388
Basic UDI-DI: 805969385K816MMTKY
Reference / catalog number: K816411
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)08059693850388

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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.

V0899MEDICAL SUPPORT EQUIPMENT - 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

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