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Organization name
UDI-DI code
Reference / catalog number

0302680 — Class I MDD by FRANKA EMIKA GmbH

MD Atlas
FRANKA EMIKA GmbH

EUDAMED last updated this device on Mar 22, 2022

0302680

B-0302680UX

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: FRANKA EMIKA GmbH
UDI-DI code: D-0302680UX
Reference / catalog number: 0302680

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Manufacturer information

Organization name: FRANKA EMIKA GmbH
SRN: DE-MF-000017899
Manufacturer status: Inactive

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: not provided
UDI-DI code: D-0302680UX
Basic UDI-DI: B-0302680UX
Reference / catalog number: 0302680
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: SR-NOCS is a device for automatic naso- and oropharyngeal swabs as performed for diagnosis of highly infectious diseases like COVID-19. The goal is to minimize the contact between healthcare workers (HCWs) and patients. The system consists of the following components: 1. Franka Emika robot system, consisting of robot arm, control and hand (gripper), emergency stop. 2. Disposable cover for robot arm 3. Smear stick for actual test 4. Disposable positioning mask to help the patient in self-positioning, changed by the robot between tests 5. Robot gripper fingers to handle smear stick and positioning mask 6. Safety electronics to guarantee safe robot operation 7. Robot cell, consisting of multiple sub modules: a. Structure with robot mount, acrylic glass walls and perforated side shielding b. Positioning mask frame with locking mechanism c. Patient control pedals d. Operator control pedal e. Station status indicator f. Process status indicator g. Slide for positioning plate feed h. Electronic unit i. Disinfectant bath for gripper fingers j. Waste container k. Operator tray for testing equipment
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - 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

This device is not currently linked to any other device.

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.