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Accutron Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 53035-12Model Nasal Hood
by Accutron
Identity
- Trade Name
- Accutron Inc. EUDAMEDAxess Mask, Medium Bubblegum, 24 Pk FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Model / Reference
- Nasal Hood EUDAMED53035-12 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 53035-12 FDA UDI
- Primary DI / UDI-DI
- 00813830026719 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813830026719 EUDAMED
- FDA Product Code
- KHA FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5590 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia face mask, single-use
Accutron Inc. by Accutron — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813830026719 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Accutron
- EUDAMED SRN
- US-MF-000009363
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 817fec47-c767-4952-902b-e1bad2970d03 61 fields · synced May 30, 2026
- FDA UDI 2d25e883-2f67-42c6-9ea7-3615d23aef26 33 fields · synced May 30, 2026