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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

Apis Matrice — Class I MDR by APIS-DENTAL Dr. Peter…

MD Atlas
APIS-DENTAL Dr. Peter Endres Inhaber Reinold Specks

EUDAMED last updated this device on Nov 9, 2023

Apis Matrice

PP11703APISMATRIZE.I.A90

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: APIS-DENTAL Dr. Peter Endres Inhaber Reinold Specks
UDI-DI code: 13117033304162
Reference / catalog number: 3304

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Manufacturer information

Organization name: APIS-DENTAL Dr. Peter Endres Inhaber Reinold Specks
SRN: DE-MF-000013335
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW011
Contains nickel: Clarify predisposition to allergic reactions beforehand. Contains small parts that could be swallowed.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: Apis Matrice
UDI-DI code: 13117033304162
Basic UDI-DI: PP11703APISMATRIZE.I.A90
Reference / catalog number: 3304
Issuing entity: IFA

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Les bandes-matrice APIS et les portes-matrice APIS dont elles sont assorties sont utilisés comme accessoires de dentisterie, dans le traitement de lésions carieuses sur une dent particulière. Ils interviennent, après élimination de la carie, comme support de modelage dans l’opération de remplissage de la cavité avec du composite plastique.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0199ODONTOLOGY 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

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.