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Organization name
UDI-DI code
Reference / catalog number

12BB02 — Class IIb MDD by Moeck & Moeck GmbH

MD Atlas
Moeck & Moeck GmbH

EUDAMED last updated this device on Apr 15, 2024

12BB02

B-04260217291042

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Moeck & Moeck GmbH
UDI-DI code: 04260217291042
Reference / catalog number: 12BB02

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Manufacturer information

Organization name: Moeck & Moeck GmbH
SRN: DE-MF-000007979
Manufacturer status: Active

Related devices

12BB-DE-EF426021729BB921S3On the market 12BB-EN-EF426021729BB921S3On the market 12BB-FR-EF426021729BB921S3On the market 12BB-IT-EF426021729BB921S3On the market 12BB-PT-EF426021729BB921S3On the market

Critical warnings

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

CW010
Warming of ischaemic limbs • Warming of body parts distal to an arterial clamp can cause burns if not monitored! • Any application where influencing the patient's body temperature is medically contraindicated • It should be noted that heat therapy can increase the effectiveness or supply of medicines to patients, which may cause harm to patients

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260217291042
Basic UDI-DI: B-04260217291042
Reference / catalog number: 12BB02
Issuing entity: GS1

Classification

Risk category: Class IIb
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)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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.