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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

017000RO0305 — Class IIb MDR by European Pharma Group…

MD Atlas
European Pharma Group B.V.

EUDAMED last updated this device on May 25, 2026

017000RO0305

871850376INS001H4

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: European Pharma Group B.V.
UDI-DI code: 08718503763897
Reference / catalog number: 017000RO0305

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View device family (Basic UDI)

Manufacturer information

Organization name: European Pharma Group B.V.
SRN: NL-MF-000021390
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

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

CW010
Consult instructions for use symbol
CW007
Do not use if package is damaged symbol
CW001
Do not re-sterilize symbol
CW262
Single patient multiple use symbol
CW999
non-pyrogenic symbol
CW999
Sterilized using ethylene oxide
CW999
DO NOT RE-USE MORE THAN 56 TIMES symbol

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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	Mar 20, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08718503763897
Basic UDI-DI: 871850376INS001H4
Reference / catalog number: 017000RO0305
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 5 per pachet
Additional information URL: https://insujet.com/users/
Clinical sizes: 0.5 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - 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

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