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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

SPF216 — Class III MDD by LABORATOIRES VIVACY

MD Atlas
LABORATOIRES VIVACY

EUDAMED last updated this device on Apr 10, 2026

SPF216

B-SPF216GM

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABORATOIRES VIVACY
UDI-DI code: D-SPF216GM
Reference / catalog number: SPF216

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Manufacturer information

Organization name: LABORATOIRES VIVACY
SRN: FR-MF-000003771
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Romania; available across 2 countries total.

Country	On market since	Until
RomaniaPrimary placement		Still on market
Sweden		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-SPF216GM
Basic UDI-DI: B-SPF216GM
Reference / catalog number: SPF216
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

X0303SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE

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

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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.