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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

C-NHCA 0.60 — Class IIa MDD by Medifill Ltd

MD Atlas
Medifill Ltd

EUDAMED last updated this device on Feb 8, 2024

C-NHCA 0.60

B-05391543260026

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Medifill Ltd
UDI-DI code: 05391543260026
Reference / catalog number: C-NHCA 0.60

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Manufacturer information

Organization name: Medifill Ltd
SRN: IE-MF-000010282
Manufacturer status: Active

Related devices

C-NBCA 0.60B-05391543260002On the market

Critical warnings

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

CW018
Refer to the IFU.

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: not provided
UDI-DI code: 05391543260026
Basic UDI-DI: B-05391543260026
Reference / catalog number: C-NHCA 0.60
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: CutisSeal Topical H sterile skin adhesive is intended for topical application in the closure of easily opposable minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations.
Additional information URL: https://cutisseal.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

H90010102SYNTHETIC GLUES

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

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.