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Organization name
UDI-DI code
Reference / catalog number

3010030 — Class IIa MDD by SPIGGLE & THEIS…

MD Atlas
SPIGGLE & THEIS Medizintechnik GmbH

EUDAMED last updated this device on Jun 30, 2022

3010030

B-04250676706140

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SPIGGLE & THEIS Medizintechnik GmbH
UDI-DI code: 04250676706140
Reference / catalog number: 3010030

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Manufacturer information

Organization name: SPIGGLE & THEIS Medizintechnik GmbH
SRN: DE-MF-000006647
Manufacturer status: Active

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Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 12, 2016	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04250676706140
Basic UDI-DI: B-04250676706140
Reference / catalog number: 3010030
Issuing entity: GS1

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: ENT-single-use suction tubes, angled, rounded tip, suction control on side, 100x3.0 mm, sterile, 50 pieces/box
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A060102SURGICAL DRAINAGE CONNECTION MEDICAL TUBES

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.