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Organization name
UDI-DI code
Reference / catalog number

Healing Abutment — Class IIb MDD by Biodenta Swiss AG

MD Atlas
Biodenta Swiss AG

EUDAMED last updated this device on Mar 21, 2024

Healing Abutment

B-07640169730047

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Biodenta Swiss AG
UDI-DI code: 07640169730047
Reference / catalog number: HA-B2040B1H

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Manufacturer information

Organization name: Biodenta Swiss AG
SRN: CH-MF-000034374
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.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Jun 16, 2014	May 24, 2024
Türkiye	Jun 16, 2014	May 24, 2024

Device identification

Trade name: Healing Abutment
UDI-DI code: 07640169730047
Basic UDI-DI: B-07640169730047
Reference / catalog number: HA-B2040B1H
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Healing Abutment / B1 / yellow / D 4.0 / GH 2.0 / BL & TP
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 4 MU50

EMDN nomenclature code(s)

P01020180DENTAL IMPLANTS - ACCESSORIES

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