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Organization name
UDI-DI code
Reference / catalog number

OHA Orthèse Herbst Amoric S — Class I MDR by Fulcrum

MD Atlas
Fulcrum

EUDAMED last updated this device on Feb 6, 2026

OHA Orthèse Herbst Amoric S

3770024630008UZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fulcrum
UDI-DI code: 03770024630176
Reference / catalog number: 1.12

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Manufacturer information

Organization name: Fulcrum
SRN: FR-MF-000015624
Manufacturer status: Active

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: OHA Orthèse Herbst Amoric S
UDI-DI code: 03770024630176
Basic UDI-DI: 3770024630008UZ
Reference / catalog number: 1.12
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: Kiit Bielle Amoric S
Additional information URL: https://www.fulcrum.fr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010499ORTHODONTIC DEVICES - 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

OHA Orthèse Herbst Amoric C3770024630008UZOn the market 1.823770024630008UZOn the market 1.813770024630008UZOn the market 1.713770024630008UZOn the market 1.63770024630008UZOn 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.