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Organization name
UDI-DI code
Reference / catalog number

Spirotome SS‐16-FL — Class IIa MDR by Bioncise NV

MD Atlas
Bioncise NV

EUDAMED last updated this device on Mar 19, 2026

Spirotome SS‐16-FL

5407005001035PU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bioncise NV
UDI-DI code: 05407005001301
Reference / catalog number: 05407005001301

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Manufacturer information

Organization name: Bioncise NV
SRN: BE-MF-000000875
Manufacturer status: Active

Critical warnings

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

CW010
CONSULT FIRST IFU

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Sep 9, 2025	Sep 9, 2025

Device identification

Trade name: Spirotome SS‐16-FL
UDI-DI code: 05407005001301
Basic UDI-DI: 5407005001035PU
Reference / catalog number: 05407005001301
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 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: 20 MU10

EMDN nomenclature code(s)

A01020199NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER

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.