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Organization name
UDI-DI code
Reference / catalog number

09155632 — Class IIa MDD by Deltamedica GmbH

MD Atlas
Deltamedica GmbH

EUDAMED last updated this device on May 26, 2024

09155632

B-04260081270655

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Deltamedica GmbH
UDI-DI code: 04260081270655
Reference / catalog number: 09155632

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Manufacturer information

Organization name: Deltamedica GmbH
SRN: DE-MF-000006440
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Nov 5, 2011	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260081270655
Basic UDI-DI: B-04260081270655
Reference / catalog number: 09155632
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: Sterile eye irrigation solution (Balanced Salt Solution) Not for intravenous infusion.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 250 MU48

EMDN nomenclature code(s)

Q02030203OPHTHALMIC SURGERY BALANCED SALINE SOLUTIONS

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

Related devices

03567718B-04260081270051On the market Deltamax NaCl 0,9% Irrigation solutionB-04260081270037On the market Deltamax NaCl 0,9% Irrigation solution DeltamedicaB-04260081270044On the market 04026456B-04260081270075On the market 04026433B-04260081270068On the market

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.