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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

Série Opal Evo Ø 1,4 — Class IIa MDD by APOL

MD Atlas
APOL

EUDAMED last updated this device on Jul 29, 2025

Série Opal Evo Ø 1,4

B-36653600004104

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: APOL
UDI-DI code: 36653600004104
Reference / catalog number: PI81010

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Manufacturer information

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

Related devices

Alésoir Ø 1,2 bague blancheB-36653600017760On the market Alésoir Ø 1,3 bague jauneB-36653600017692On the market Alésoir Ø 1,4 bague rougeB-36653600017524On the market Alésoir Ø 1,5 bague bleueB-36653600017456On the market Alésoir Ø 1,6 bague verteB-36653600017388On 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

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: Série Opal Evo Ø 1,4
UDI-DI code: 36653600004104
Basic UDI-DI: B-36653600004104
Reference / catalog number: PI81010
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Tenon pour prise d'empreinte dentaire + alésoir
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010299PROSTHETIC DENTISTRY 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

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Expiration date
Manufacturing date
Serial number
Software identification