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Organization name
UDI-DI code
Reference / catalog number

975387 — Class IIa MDR by BODE Chemie GmbH

MD Atlas
BODE Chemie GmbH

EUDAMED last updated this device on Mar 19, 2024

975387

40316782723LJ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BODE Chemie GmbH
UDI-DI code: 04031678037933
Reference / catalog number: 975387

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Manufacturer information

Organization name: BODE Chemie GmbH
SRN: DE-MF-000005851
Manufacturer status: Active

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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.

Critical warnings

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

CW076
EUDAMED did not publish a description for this code.
CW082
EUDAMED did not publish a description for this code.
CW088
EUDAMED did not publish a description for this code.
CW084
EUDAMED did not publish a description for this code.
CW089
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW103
EUDAMED did not publish a description for this code.
CW105
EUDAMED did not publish a description for this code.
CW119
EUDAMED did not publish a description for this code.
CW159
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW171
EUDAMED did not publish a description for this code.
CW999
Dispose of contents/container to an approved waste disposal plant.
CW104
EUDAMED did not publish a description for this code.
CW401
EUDAMED did not publish a description for this code.
CW299
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW397
EUDAMED did not publish a description for this code.
CW179
EUDAMED did not publish a description for this code.
CW185
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 1997	Nov 7, 2025
Austria	Jan 1, 2002	Nov 7, 2025

Device identification

Trade name: not provided
UDI-DI code: 04031678037933
Basic UDI-DI: 40316782723LJ
Reference / catalog number: 975387
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 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)

D01010101GLUTARALDEHYDE, BASIC SOLUTION FOR THE DISINFECTION OF MEDICAL 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