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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

FC-1L — Class I MDR by TIMS - TECNOLOGIA…

MD Atlas
TIMS - TECNOLOGIA INOVADORA MAIS SEGURA, LDA (ZONA FRANCA DA MADEIRA)

EUDAMED last updated this device on Nov 5, 2025

FC-1L

5600760338HDFSUP3R

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TIMS - TECNOLOGIA INOVADORA MAIS SEGURA, LDA (ZONA FRANCA DA MADEIRA)
UDI-DI code: 05600760338037
Reference / catalog number: FC-1L

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View device family (Basic UDI)

Manufacturer information

Organization name: TIMS - TECNOLOGIA INOVADORA MAIS SEGURA, LDA (ZONA FRANCA DA MADEIRA)
SRN: PT-MF-000040052
Manufacturer status: Active

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Critical warnings

3 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.
CW030
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Portugal; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05600760338037
Basic UDI-DI: 5600760338HDFSUP3R
Reference / catalog number: FC-1L
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: Large Memory Foam (MF) Prone Face Cushion
Additional information URL: https://tims.pt/products/ifu/IFU_25_FC-1L.pdf
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)05600760338037

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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.

V080302PATIENT POSITIONING MEDICAL CUSHIONS

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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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.