← Back to catalogue

Plasti-Med

EUDAMED

Class IIa (EU MDR)

Ref 130373

by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.

Identity

Trade Name: PLASTI-MED EUDAMED
Device Name: DISPOSABLE RESUSCITATOR DEVICE SET ADULT (GUEDEL AIRWAY NO 4/90, INFLATABLE MASK NO 4 EUDAMED
Model / Reference: 130373 EUDAMED

Identifiers

Primary DI / UDI-DI: 08698573039286 EUDAMED
Basic UDI-DI: B-08698573039286 EUDAMED
EMDN Code: R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Pulmonary resuscitator, manual, single-use

Plasti-Med by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary resuscitator, manual, single-use.

Ventlab — Ventlab Corp. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
VT Sure — Pulmodyne Inc. · Class II
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
Ventlab — Ventlab Corp. · Class I
Ventlab — Ventlab Corp. · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.
EUDAMED SRN: TR-MF-000032251

Sources (1)

EUDAMED 8c1a4d23-244b-4b16-8565-21133177c97d 61 fields · synced Jun 18, 2026