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Organization name
UDI-DI code
Reference / catalog number

Bone Level Fixture Hybrid — Class IIb MDD by Novodent SA

MD Atlas
Novodent SA

EUDAMED last updated this device on Apr 8, 2026

Bone Level Fixture Hybrid

B-07640168180133

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Novodent SA
UDI-DI code: 07640168180133
Reference / catalog number: S-BFHR4808

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Manufacturer information

Organization name: Novodent SA
SRN: CH-MF-000023309
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

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Jul 1, 2019	Still on market

Device identification

Trade name: Bone Level Fixture Hybrid
UDI-DI code: 07640168180133
Basic UDI-DI: B-07640168180133
Reference / catalog number: S-BFHR4808
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: Bone Level Fixture Hybrid , Ø 4.8×8mm
Additional information URL: https://ifu.implantswiss.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P01020101DENTAL IMPLANTS

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