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Welch Allyn 94018-0000

EUDAMED

Class I (EU MDR)

Ref SK-WA-210280-200RS1Model SKYMEDRef SK-WA-210280-200RSRef ACC-WA210280/200RSModel Accu-PlusRef SK-WA210280-200RSRef SK-WA210280-200RS1Ref APP-WA210280-200RSModel ALPHA-PLUS

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
WELCH ALLYN 94018-0000 EUDAMED
WELCH ALLYN 94016-0000 EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
SKYMED EUDAMED
SK-WA-210280-200RS1 EUDAMED
SK-WA-210280-200RS EUDAMED
Accu-Plus EUDAMED
ACC-WA210280/200RS EUDAMED
SK-WA210280-200RS EUDAMED
SK-WA210280-200RS1 EUDAMED
ALPHA-PLUS EUDAMED
APP-WA210280-200RS EUDAMED

Identifiers

Primary DI / UDI-DI
09551019810636 EUDAMED
09551026271543 EUDAMED
09551019815365 EUDAMED
09551026273547 EUDAMED
Basic UDI-DI
955101981MCRP-SMPY EUDAMED
955102627MCRP-SMMG EUDAMED
955101981MCRP-APNG EUDAMED
955102627MCRPAPFF EUDAMED
Direct Marketing DI
09551019810636 EUDAMED
09551026271543 EUDAMED
09551019815365 EUDAMED
09551026273547 EUDAMED
EMDN Code
Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED

Classification

Device Class
Class I EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Welch Allyn 94018-0000 by Isd Meditech Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
MY-MF-000043531
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (6)

  • EUDAMED 84566d92-f48e-4a47-bd17-e457967b5966 61 fields · synced Aug 4, 2026
  • EUDAMED c792de68-c9ef-4ca9-b9d0-17a9873a0e5b 61 fields · synced May 17, 2026
  • EUDAMED 830441a9-364b-49ca-b2cf-14763d9b23de 61 fields · synced May 17, 2026
  • EUDAMED bb7122c0-8266-4695-8b2c-e564d3b21b93 61 fields · synced Jun 19, 2026
  • EUDAMED 16ebc733-1c54-49f0-bf45-b42ec903ef83 61 fields · synced Jul 15, 2026
  • EUDAMED 96af3623-d8db-4848-ac6a-850beb10e4ea 61 fields · synced Aug 4, 2026