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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

SPF215 — Class III MDD by LABORATOIRES VIVACY

MD Atlas
LABORATOIRES VIVACY

EUDAMED last updated this device on Apr 10, 2026

SPF215

B-SPF215GK

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABORATOIRES VIVACY
UDI-DI code: D-SPF215GK
Reference / catalog number: SPF215

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Manufacturer information

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

Related devices

SPF217B-SPF217GPOn the market SPF243B-03760208530545On the market SPF471B-03760208533980On the market SPF555B-03760208535427On the market SPF250B-03760208530385On the market

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-SPF215GK
Basic UDI-DI: B-SPF215GK
Reference / catalog number: SPF215
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

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.