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

LED 610 Light source — Class I MDR by Erbe Vision GmbH

MD Atlas
Erbe Vision GmbH

EUDAMED last updated this device on Jun 7, 2024

LED 610 Light source

426021465000IlluminateW8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Erbe Vision GmbH
UDI-DI code: 04260214650194
Reference / catalog number: 10820-000

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: Erbe Vision GmbH
SRN: DE-MF-000010268
Manufacturer status: Active

Related devices

Adaptor for resectoscope inner sheath426021465ADAPTERSEEOn the market Adaptor for resectoscope outer sheath426021465ADAPTERSEEOn the market Deflecting Obturator f. resectoscope sheath426021465OBTURATORSA5On the market Endoscope wire basket426021465WIREBASKET48On the market Fiberoptic cable Ø 4.8 mm; L 3m426021465FOCC3On the market

Critical warnings

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

CW999
The LED-610 light source is contraindicated for use in neonate transillumination, ophthalmic procedures, photosensitive person, or person receiving photosensitizing agents (hematoporphyrin derivatives) within 90 days.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: LED 610 Light source
UDI-DI code: 04260214650194
Basic UDI-DI: 426021465000IlluminateW8
Reference / catalog number: 10820-000
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Power frequency: 50 / 60 Hz System voltage: 100-120 / 200-240 V Potential equalization connection: yes IP-Class: IP20 Power consumption: 150 W Applied Part: Type BF Light temperature: 6000K"
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12020402LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY

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.