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Positive Expiratory Pressure (PEP) Therapy device

EUDAMED

Class I (EU MDR)

Ref 8020040Ref 8020045Ref 8020015Ref 8020025Ref 8020050

by Intersurgical Ltd

Identity

Device Name
Positive Expiratory Pressure (PEP) Therapy device EUDAMED
Model / Reference
8020040 EUDAMED
8020045 EUDAMED
8020015 EUDAMED
8020025 EUDAMED
8020050 EUDAMED

Identifiers

Primary DI / UDI-DI
05030267160846 EUDAMED
05030267160389 EUDAMED
05030267160938 EUDAMED
05030267160990 EUDAMED
05030267160815 EUDAMED
Basic UDI-DI
05030267PEPTHERER EUDAMED
EMDN Code
Z12159009 EQUIPMENT FOR REMOVAL OF SECRETIONS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Sweden 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Positive Expiratory Pressure (PEP) Therapy device by Intersurgical Ltd — 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

Manufacturer
Intersurgical Ltd
EUDAMED SRN
GB-MF-000004798
Authorised Representative
UAB Intersurgical LT-AR-000003907

Sources (5)

  • EUDAMED a28982ee-96f5-4c56-a741-c9df358963f4 61 fields · synced Sep 17, 2026
  • EUDAMED 3359a709-b06a-44b7-bcff-0001ec5b2319 61 fields · synced May 17, 2026
  • EUDAMED c1e935e5-a47f-465c-ac79-cecc74a87b03 61 fields · synced May 18, 2026
  • EUDAMED 28e5e253-a797-4978-a5c1-a9e13e580404 61 fields · synced May 18, 2026
  • EUDAMED 2d3e4e9a-21dd-4db6-99f4-6341fe6d35de 61 fields · synced May 19, 2026