EUDAMED last updated this device on Jul 21, 2026

THE Graft

B-08800039000130

On the marketClass III

Applicable legislation: —
Organization name: Purgo Biologics Inc.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08800039000130
Reference / catalog number: TG-AS05

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

THE Graft is an EU-regulated medical device registered in EUDAMED. It is classified as Class III. Manufactured by Purgo Biologics Inc.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: THE Graft
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08800039000130
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-08800039000130
Reference / catalog number: TG-AS05
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class III
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: THE Graft is a natural and porous bone mineral matrix consisted of HA [Hydroxyapatite]. It is manufactured by removal of all organic components from porcine bone. Due to its natural structure the anorganic bone mineral of THE Graft likens physical and chemical aspects of mineralized matrix of human bone. When packed into a bone defect, THE Graft gradually resorbs and is replaced with bone during the healing process. It is available in cancellous granules packaged in vial and syringe. THE Graft is provided sterile by gamma irradiation and sterility of THE Graft is valid 5 years after sterilization, but expected lifetime is depends on dental implant.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08800039000130

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q010302DENTAL GRAFT DEVICES

Critical warnings

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

Do not re-use
Do not use if package is damaged
Contains biological material of animal origin

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jan 8, 2020	Still on market

THE Graft

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Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

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Safety

Regulatory

Lifecycle

Market distribution

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Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

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Certificates covering this device

Legacy certificates

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