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Baldus Innenmaske Pediatric, autoklavierbar
EUDAMEDClass IIa (EU MDR)
Ref 16033Model Baldus Doppelnasenmasken-Scavengersystem
Identity
- Trade Name
- Baldus Innenmaske Pediatric, autoklavierbar EUDAMED
- Device Name
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Happy Apple EUDAMED
- Model / Reference
- Baldus Doppelnasenmasken-Scavengersystem EUDAMED16033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260635790172 EUDAMED
- Basic UDI-DI
- 426063579MASKCG EUDAMED
- Direct Marketing DI
- 04260635790172 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Anaesthesia face mask, single-use
Baldus Innenmaske Pediatric, autoklavierbar by Baldus Sedation GmbH & Co. KG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426063579MASKCG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Baldus Sedation GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006223
Sources (1)
- EUDAMED 2e395b99-7105-49a4-932e-59ba26d9cd2f 61 fields · synced Jul 11, 2026