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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

SHEETSPLINT — Class I MDR by ETHR OÜ

MD Atlas
ETHR OÜ

EUDAMED last updated this device on Feb 13, 2023

SHEETSPLINT

47450110242S032MG1K6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ETHR OÜ
UDI-DI code: 04745011024213
Reference / catalog number: S032MG1

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Manufacturer information

Organization name: ETHR OÜ
SRN: EE-MF-000032039
Manufacturer status: Active

Market distribution

Primary placement in Estonia; available across 1 country total.

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

Device identification

Trade name: SHEETSPLINT
UDI-DI code: 04745011024213
Basic UDI-DI: 47450110242S032MG1K6
Reference / catalog number: S032MG1
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: SHEETSPLINT™️ UNIVERSAL MODULAR SPLINT is a universal modular splint for civilian and tactical first responders. The device is primarily intended to be used in pre-hospital trauma settings. Sheetsplint provides temporary immobilisation to extremity injuries and facilitates safe evacuation to a higher level of care. The device is intended to be used by medical professionals.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M03050299BANDAGES AND SPLINTS - 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

Related devices

SHEETSPLINT™️ UNIVERSAL MODULAR SPLINT47450110242S032MG4KCOn the market SHEETSPLINT™️ UNIVERSAL MODULAR SPLINT47450110242S032MG2K8On 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.