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Ceren
EUDAMEDClass IIa (EU MDR)
Ref AM 2030 2071 Model DISPOSABLE ARTIFICIAL RESPIRATOR - PEDIATRIC
by Ceren Üreti̇m Plasti̇k Ürünleri̇ Sanayi̇ Ti̇caret Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- CEREN EUDAMED
- Device Name
- DISPOSABLE ARTIFICIAL RESPIRATOR EUDAMED
- Model / Reference
- DISPOSABLE ARTIFICIAL RESPIRATOR - PEDIATRIC EUDAMEDAM 2030 2071 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681227070629 EUDAMED
- Basic UDI-DI
- B-08681227070629 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
Ceren by Ceren Üreti̇m Plasti̇k Ürünleri̇ Sanayi̇ Ti̇caret Anoni̇m Şi̇rketi̇ — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, single-use.
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- 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08681227070629 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022140
Sources (1)
- EUDAMED 6b6c1bce-f80f-414c-bf32-a3bbff67bab8 61 fields · synced Oct 6, 2026