Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

A-HEA060 — Class III MDD by Aptissen SA

MD Atlas
Aptissen SA

EUDAMED last updated this device on May 15, 2024

A-HEA060

B-07640164440293

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Aptissen SA
UDI-DI code: 07640164440293
Reference / catalog number: A-HEA060

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Aptissen SA
SRN: CH-MF-000019305
Manufacturer status: Active

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
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.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jun 2, 2015	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07640164440293
Basic UDI-DI: B-07640164440293
Reference / catalog number: A-HEA060
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: HEALAFLOW® is filled into glass syringe and packed into sealed, sterile pouch. The secondary packaging contains the pouch with the syringe and a CE-marked sterile needle of size 25G x 7/8″ for the product‘s administration and patients labels. To be used by ophthalmic surgeons only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A02010799PREFILLED SYRINGES - 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

Related devices

A-VIS1.0B-07640164440156On the market A-SYN200B-07640164440163On the market A-SYN400B-07640164440217On 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.