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Resuscitator
EUDAMEDClass I (EU MDR)
Ref N/AModel XH-KB04,XH-KB05,XH-KB06,XH- KB07 ,XH-KB09,XH-KB10,YXH- M01
by Zhangjiagang Xiehe Medical Apparatus&Instruments Co., Ltd.
Identity
- Device Name
- Resuscitator EUDAMED
- Model / Reference
- XH-KB04,XH-KB05,XH-KB06,XH- KB07 ,XH-KB09,XH-KB10,YXH- M01 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974580877151 EUDAMED
- Basic UDI-DI
- 6974580870008E4 EUDAMED
- EMDN Code
- R020399 ANESTHESIA AND RESUSCITATION CONNECTORS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Resuscitator by Zhangjiagang Xiehe Medical Apparatus&Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6974580870008E4 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000008449
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED afd5cfd5-52a1-4a0f-9677-1188cc1438c1 61 fields · synced Oct 7, 2026
- EUDAMED afd5cfd5-52a1-4a0f-9677-1188cc1438c1-1 61 fields · synced Jun 10, 2026