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Organization name
UDI-DI code
Reference / catalog number

Tenons Fibreglass Rose Ø1,2 L12 — Class IIa MDD by APOL

MD Atlas
APOL

EUDAMED last updated this device on Jul 30, 2025

Tenons Fibreglass Rose Ø1,2 L12

B-36653600033364

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: APOL
UDI-DI code: 36653600033364
Reference / catalog number: WP25085

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Manufacturer information

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

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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.

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: Tenons Fibreglass Rose Ø1,2 L12
UDI-DI code: 36653600033364
Basic UDI-DI: B-36653600033364
Reference / catalog number: WP25085
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 dentaire définitif
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1.2 MU50
12 MU50

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