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Organization name
UDI-DI code
Reference / catalog number

OT0308 — Class I MDR by Allion BV h.o.d.n. van…

MD Atlas
Allion BV h.o.d.n. van Heek Medical

EUDAMED last updated this device on Feb 12, 2024

OT0308

8715886KraamEnOnderlegUV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Allion BV h.o.d.n. van Heek Medical
UDI-DI code: 08715886022061
Reference / catalog number: OT0308

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View device family (Basic UDI)

Manufacturer information

Organization name: Allion BV h.o.d.n. van Heek Medical
SRN: NL-MF-000003490
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

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

CW009
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Sep 7, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08715886022061
Basic UDI-DI: 8715886KraamEnOnderlegUV
Reference / catalog number: OT0308
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 50
Additional product description: kraammatras
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 70 MU10
180 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08715886022061

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

T04010201UNTUCKABLE UNDERPADS

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

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