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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

PL0035 — 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 13, 2024

PL0035

8715886TapeME

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: 08715886007853
Reference / catalog number: PL0035

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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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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	Jun 6, 2014	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08715886007853
Basic UDI-DI: 8715886TapeME
Reference / catalog number: PL0035
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: 6
Additional product description: hechtpleister non-woven
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 5 MU36
2.5 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08715886007853

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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.

M0599MEDICAL PLASTERS - 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

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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.