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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

Ti Or Opal / Ø 1,4 / L 9,5 — Class I MDR by APOL

MD Atlas
APOL

EUDAMED last updated this device on Apr 14, 2025

Ti Or Opal / Ø 1,4 / L 9,5

3665360TEMP.OPALHH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: APOL
UDI-DI code: 36653600000458
Reference / catalog number: PI20165

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Manufacturer information

Organization name: APOL
SRN: FR-MF-000001707
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Les contre-indications, mises en garde/précautions et préconisations d'utilisation sont listés dans la notice

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium		Still on market
Luxembourg		Still on market

Device identification

Trade name: Ti Or Opal / Ø 1,4 / L 9,5
UDI-DI code: 36653600000458
Basic UDI-DI: 3665360TEMP.OPALHH
Reference / catalog number: PI20165
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: Tenon pour prise d'empreinte dentaire
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1.4 MU50
9.5 MU50

EMDN nomenclature code(s)

Q010105RECONSTRUCTION ENDODONTIC PINS

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

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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.