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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

NL-F15-TQD — Class I MDR by First15 B.V.

MD Atlas
First15 B.V.

EUDAMED last updated this device on Oct 7, 2024

NL-F15-TQD

87202994175F15-TQ2F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: First15 B.V.
UDI-DI code: 08720299417564
Reference / catalog number: NL-F15-TQD

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View device family (Basic UDI)

Manufacturer information

Organization name: First15 B.V.
SRN: NL-MF-000001844
Manufacturer status: Active

Related devices

First15 Tactical Tourniquet87202994175F15-TQ2FOn the market First15 Tourniquet87202994175F15-TQ2FOn the market First15 Tourniquet Dutch Police87202994175F15-TQ2FOn the market First15 Training Tourniquet Dutch Police87202994175F15-TQ2FOn the market NL-F15-TT87202994175F15-TQ2FOn 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

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

CW009
Single use product
CW022
Do not cut
CW010
Consult instructions before use

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Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08720299417564
Basic UDI-DI: 87202994175F15-TQ2F
Reference / catalog number: NL-F15-TQD
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: A single use medical tourniquet
Additional information URL: https://www.first15.eu/nl/instructies/
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.

C90010301HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)

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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