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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

EZ-IO 15mm Needle Set — Class IIa MDD by Teleflex Medical

MD Atlas
Teleflex Medical

EUDAMED last updated this device on May 12, 2026

EZ-IO 15mm Needle Set

B-10816000013912

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Teleflex Medical
UDI-DI code: 10816000013912
Reference / catalog number: 9018-VC-001

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Manufacturer information

Organization name: Teleflex Medical
SRN: IE-MF-000015868
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

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

CW999
Do not resterilize
CW999
Do not use if package is damaged
CW999
Do not re-use
CW999
Consult instructions for use
CW999
Caution
CW999
MR CONDITIONAL

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: EZ-IO 15mm Needle Set
UDI-DI code: 10816000013912
Basic UDI-DI: B-10816000013912
Reference / catalog number: 9018-VC-001
Issuing entity: GS1

Classification

Risk category: Class IIa
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)

A019011INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS

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