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CPR face shield
EUDAMEDClass I (EU MDR)
Ref ZA-I01Model ZA-I01, ZA-I02, ZA-I03, ZA-I04, ZA-I05
Identity
- Trade Name
- CPR face shield EUDAMED
- Device Name
- CPR face shield EUDAMED
- Model / Reference
- ZA-I01, ZA-I02, ZA-I03, ZA-I04, ZA-I05 EUDAMEDZA-I01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979499220463 EUDAMED
- Basic UDI-DI
- 697949922CFS001SW EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Anaesthesia face mask, single-use
CPR face shield by Hengshui Zhong'an Medical Supplies Co., 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 | 697949922CFS001SW | Class I | Active |
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Manufacturer
- Manufacturer
- Hengshui Zhong'an Medical Supplies Co., Ltd
- EUDAMED SRN
- CN-MF-000051451
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d3be2e19-e273-4fa9-b130-dbe613fd6926 61 fields · synced Jul 9, 2026