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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

ERGOTECH RED — Class I MDR by FDI FRANCE

MD Atlas
FDI FRANCE

EUDAMED last updated this device on Feb 16, 2023

ERGOTECH RED

3665155CanAngBT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FDI FRANCE
UDI-DI code: 03665155000212
Reference / catalog number: ET/04/06

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Manufacturer information

Organization name: FDI FRANCE
SRN: FR-MF-000023166
Manufacturer status: Active

Related devices

ASW/05/023665155CanAngBTOn the market ACO/01/023665155CanAngBTOn the market ACO/05/023665155CanAngBTOn the market ACO/04/023665155CanAngBTOn the market ACO/03/023665155CanAngBTOn 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.

CW010
EUDAMED did not publish a description for this code.
CW275
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: ERGOTECH RED
UDI-DI code: 03665155000212
Basic UDI-DI: 3665155CanAngBT
Reference / catalog number: ET/04/06
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: ELBOW CRUTCH ERGOTECH RED GRIP : YELLOW
Additional information URL: https://www.fdifrance.com/
Clinical sizes: maxi 130 kgs

EMDN nomenclature code(s)

Y12030602CRUTCHES WITH ANTIBRACHIAL SUPPORT

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