Identity
- Trade Name
- JF1197 JFA Resuscitation Shield 483-1# EUDAMED
- Device Name
- Resuscitation Shield EUDAMED
- Model / Reference
- JF1197 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864851634 EUDAMED
- Basic UDI-DI
- 697386485JFACPRVB EUDAMED
- Direct Marketing DI
- 06973864851634 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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: Pulmonary resuscitator, manual, single-use
JF1197 JFA Resuscitation Shield 483-1# by Suzhou Sunmed Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, single-use.
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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 | 697386485JFACPRVB | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8c84e9a5-e37c-4be2-8f83-49466075275a 61 fields · synced Oct 5, 2026
- EUDAMED 4deaeecf-7743-4e03-b498-e209cdc3bf03 61 fields · synced Oct 5, 2026