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Plasti-Med
EUDAMEDClass IIa (EU MDR)
Ref 130 211
by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.
Identity
- Trade Name
- PLASTI-MED EUDAMED
- Device Name
- INFLATABLE MASK NO 1 EUDAMED
- Model / Reference
- 130 211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698573038111 EUDAMED
- Basic UDI-DI
- B-08698573038111 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS 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: Anaesthesia face mask, 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
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Also classified as Anaesthesia face mask, single-use.
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- King Mask — Ambu A/S · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08698573038111 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000032251
Sources (1)
- EUDAMED 0448a4f5-5e80-426f-a64e-30a24477fee2 61 fields · synced Jun 19, 2026