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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

Helenvision Dual — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Jul 22, 2025

Helenvision Dual

B-38101GE

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-38101GE
Reference / catalog number: 38101

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Manufacturer information

Organization name: bitop AG
SRN: DE-MF-000006543
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

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

CW999
• HELENVISION DUAL should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients of the eye drops. • If allergic reactions due to the product occur, the use of HELENVISION DUAL must be discontinued immediately. • After usage of one ampoule, the remaining liquid must be discarded, it is not intended for later usage. • Do not use damaged or punctured ampoules. • HELENVISION DUAL is filled in small plastic parts that could be swallowed by small children. Danger of suffocation. Therefore, HELENVISION DUAL should be kept out of reach of children.

Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement		Still on market

Device identification

Trade name: Helenvision Dual
UDI-DI code: D-38101GE
Basic UDI-DI: B-38101GE
Reference / catalog number: 38101
Issuing entity: EUDAMED

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)

Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - 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