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Resuscitation Face Shield
EUDAMEDClass I (EU MDR)
Ref 9569-L15Ref 9589Ref 9598Ref 9589-T6Ref 9563-E10Ref 9568-L8Ref 9589-L12Ref 9572Ref 9570-D4/3Ref 9568-E12Ref 9582Ref 9597Ref 9590Ref FFK1022
Identity
- Device Name
- Resuscitation Face Shield EUDAMED
- Model / Reference
- 9569-L15 EUDAMED9589 EUDAMED9598 EUDAMED9589-T6 EUDAMED9563-E10 EUDAMED9568-L8 EUDAMED9589-L12 EUDAMED9572 EUDAMED9570-D4/3 EUDAMED9568-E12 EUDAMED9582 EUDAMED9597 EUDAMED9590 EUDAMEDFFK1022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05020581296086 EUDAMED05020581258152 EUDAMED05020581273742 EUDAMED05020581296161 EUDAMED05020581296017 EUDAMED05020581296055 EUDAMED05020581296147 EUDAMED05020581270499 EUDAMED05020581294006 EUDAMED05020581296048 EUDAMED05020581274862 EUDAMED05020581273759 EUDAMED05020581272141 EUDAMED05020581296185 EUDAMED
- Basic UDI-DI
- 5020581STE012JR EUDAMED
- Unit of Use DI
- 05020581289095 EUDAMED05020581273766 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Anaesthesia face mask, single-use
Resuscitation Face Shield by Steroplast Healthcare Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- 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 (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 | 5020581STE012JR | Class I | Active |
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Manufacturer
- Manufacturer
- Steroplast Healthcare Ltd
- EUDAMED SRN
- GB-MF-000018088
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (14)
- EUDAMED ea643cd2-e95e-4e23-9540-596775ad7c2d 61 fields · synced Aug 2, 2026
- EUDAMED 9b1ce5d9-3756-4555-b1b3-419ef4421c93 61 fields · synced May 16, 2026
- EUDAMED 48c99e23-8c01-4d56-bf97-5351ad38f7bc 61 fields · synced May 17, 2026
- EUDAMED 8d168a6e-a840-42e0-a369-3df6f63ad0a8 61 fields · synced May 17, 2026
- EUDAMED ea1e9a43-19c0-484b-8b42-760574fd5eb6 61 fields · synced May 17, 2026
- EUDAMED b6e1c35e-255c-43ad-8669-bcd948d3239f 61 fields · synced May 17, 2026
- EUDAMED 5e39619a-12f2-4038-9485-71edd95bfc85 61 fields · synced May 18, 2026
- EUDAMED f5c5f017-61d8-46f9-87b0-a2cfeceefed6 61 fields · synced May 18, 2026
- EUDAMED c5927c87-a299-45ac-8fea-c64c54eb3022 61 fields · synced May 18, 2026
- EUDAMED b63ead44-7889-4cb5-aeb2-7c494442b2ba 61 fields · synced May 18, 2026
- EUDAMED 7d3c1801-6183-45f8-ab22-ee37a3010315 61 fields · synced May 18, 2026
- EUDAMED 0b76ccef-a8c3-464d-930f-b0fe31140e2f 61 fields · synced May 19, 2026
- EUDAMED 5cc054c1-972d-4c29-9337-cc98b6b67243 61 fields · synced May 19, 2026
- EUDAMED f3dc2a7b-8b49-4e76-8dbc-53a77a4e3d91 61 fields · synced May 19, 2026