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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

Wärme-pflaster — Class IIa MDD by Dr. Kleine Pharma GmbH

MD Atlas
Dr. Kleine Pharma GmbH

EUDAMED last updated this device on May 20, 2022

Wärme-pflaster

B-000006589E6

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Dr. Kleine Pharma GmbH
UDI-DI code: D-000006589E6
Reference / catalog number: Wärme-pflaster

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Manufacturer information

Organization name: Dr. Kleine Pharma GmbH
SRN: DE-MF-000006589
Manufacturer status: Active

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Critical warnings

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

CW011
Heat
CW010
Follow the complete instructions and counter indications in the enclosed Instructions for Use and monitor the application area regularly.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 16, 2022	May 26, 2024

Device identification

Trade name: not provided
UDI-DI code: D-000006589E6
Basic UDI-DI: B-000006589E6
Reference / catalog number: Wärme-pflaster
Issuing entity: EUDAMED

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: Air-activated heat pads for pain relief.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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.