Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

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

MD Atlas
APOL

EUDAMED last updated this device on Jul 29, 2025

Série Opal Evo Ø 1,4 Maxi

B-36653600004036

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: APOL
UDI-DI code: 36653600004036
Reference / catalog number: PI81016

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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 Maxi
UDI-DI code: 36653600004036
Basic UDI-DI: B-36653600004036
Reference / catalog number: PI81016
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification