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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

TP-3438 — Class I MDR by ORTHODONTICS HIGH…

MD Atlas
ORTHODONTICS HIGH DESIGN SRL

EUDAMED last updated this device on Mar 14, 2024

TP-3438

805059378MEMOCLEARPROC3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTHODONTICS HIGH DESIGN SRL
UDI-DI code: 08050593780126
Reference / catalog number: TP-3438

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View device family (Basic UDI)

Manufacturer information

Organization name: ORTHODONTICS HIGH DESIGN SRL
SRN: IT-MF-000020077
Manufacturer status: Active

Related devices

TP-001-074/SM805059378SMARTPLIERSVFOn the market TP-001-085/SM805059378SMARTPLIERSVFOn the market 001-160805059378SPESSIMETRIZFOn the market TP-001-077/SM805059378SMARTPLIERSVFOn the market TP-001-076/SM805059378SMARTPLIERSVFOn 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

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

CW147
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement	Sep 27, 2021	Still on market
Spain		Still on market
France		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08050593780126
Basic UDI-DI: 805059378MEMOCLEARPROC3
Reference / catalog number: TP-3438
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: 20
Additional product description: 2.0mm x 125 ROUND SHEETS
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Thickness — 2 MU50
125 MU50

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.

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

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