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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

OP/04/02 — Class I MDR by FDI FRANCE

MD Atlas
FDI FRANCE

EUDAMED last updated this device on Sep 21, 2022

OP/04/02

3665155CanAngBT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FDI FRANCE
UDI-DI code: 03665155000304
Reference / catalog number: OP/04/02

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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.

CW275
EUDAMED did not publish a description for this code.
CW010
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: not provided
UDI-DI code: 03665155000304
Basic UDI-DI: 3665155CanAngBT
Reference / catalog number: OP/04/02
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 crutches PREMIUM RED
Additional information URL: https://fdifrance.com/notice
Clinical sizes: 130 KG MAX

EMDN nomenclature code(s)

Y12030601ELBOW CRUTCHES

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