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PVC Manual Resuscitator
EUDAMEDClass IIa (EU MDR)
Ref EMR0402021Model NPVC-001/RTMA1、NPVC-001/RTMA、NPVC-001/RTMA3、NPVC-002/RTMA2、NPVC-002/RTMA、NPVC-002/RTMA3、NPVC-003/RTMA、NPVC-003/RTMA2、NPVC-003/RTMA3Ref EMR0403003Model NPVC-001/S2、NPVC-001/S1、 NPVC-002/S、 NPVC-002/S2、 NPVC-003/S、NPVC-003/S2Ref EMR0403006Ref EMR0401008Model NPVC-001/RTMA2Ref EMR0401005Ref EMR0402003Model NPVC-001/RTMA1、 NPVC-001/RTMA、NPVC-002/RTMA2、NPVC-002/RTMA、NPVC-003/RTMA、NPVC-003/RTMA2Ref EMR0403016Ref EMR0402006Ref EMR0402004Model NPVC-001/S2G、NPVC-001/S1G、NPVC-002/S2G、 NPVC-003/SG、 NPVC-003/S2GRef EMR0403007Ref EMR0403005Ref TM01-026-1Ref EMR0401003Ref TDM-RES-0551Ref EMR0403002Ref EMR0401060Model Adult,Pediatric,InfantRef CP681313NRef EMR0402005Ref EMR0402023Ref EMR0402002Ref TDM-RES-0280Ref CP682113Ref EMR0406003Model Adult-H，Child-HRef TDM-RES-1500Model TDM-RES-1500、TDM-RES-1000Ref EMR0401036Ref EMR0401004Ref EMR0401002Ref TDM-RES-0550Ref CP682313Ref EMR0402029Ref 563
Identity
- Trade Name
- PVC Manual Resuscitator EUDAMED
- Device Name
- PVC Manual Resuscitator EUDAMED
- Model / Reference
- NPVC-001/RTMA1、NPVC-001/RTMA、NPVC-001/RTMA3、NPVC-002/RTMA2、NPVC-002/RTMA、NPVC-002/RTMA3、NPVC-003/RTMA、NPVC-003/RTMA2、NPVC-003/RTMA3 EUDAMEDEMR0402021 EUDAMEDNPVC-001/S2、NPVC-001/S1、 NPVC-002/S、 NPVC-002/S2、 NPVC-003/S、NPVC-003/S2 EUDAMEDEMR0403003 EUDAMEDEMR0403006 EUDAMEDNPVC-001/RTMA2 EUDAMEDEMR0401008 EUDAMEDEMR0401005 EUDAMEDEMR0402003 EUDAMEDNPVC-001/RTMA1、 NPVC-001/RTMA、NPVC-002/RTMA2、NPVC-002/RTMA、NPVC-003/RTMA、NPVC-003/RTMA2 EUDAMEDEMR0403016 EUDAMEDEMR0402006 EUDAMEDNPVC-001/S2G、NPVC-001/S1G、NPVC-002/S2G、 NPVC-003/SG、 NPVC-003/S2G EUDAMEDEMR0402004 EUDAMEDEMR0403007 EUDAMEDEMR0403005 EUDAMEDTM01-026-1 EUDAMEDEMR0401003 EUDAMEDTDM-RES-0551 EUDAMEDEMR0403002 EUDAMEDAdult,Pediatric,Infant EUDAMEDEMR0401060 EUDAMEDCP681313N EUDAMEDEMR0402005 EUDAMEDEMR0402023 EUDAMEDEMR0402002 EUDAMEDTDM-RES-0280 EUDAMEDCP682113 EUDAMEDAdult-H，Child-H EUDAMEDEMR0406003 EUDAMEDTDM-RES-1500、TDM-RES-1000 EUDAMEDTDM-RES-1500 EUDAMEDEMR0401036 EUDAMEDEMR0401004 EUDAMEDEMR0401002 EUDAMEDTDM-RES-0550 EUDAMEDCP682313 EUDAMEDEMR0402029 EUDAMED563 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430422767 EUDAMED06946430418258 EUDAMED06946430418586 EUDAMED06946430422446 EUDAMED06946430422439 EUDAMED06946430418548 EUDAMED06946430418128 EUDAMED06946430422651 EUDAMED06946430422729 EUDAMED06946430417121 EUDAMED06946430417145 EUDAMED06946430418289 EUDAMED06946430418173 EUDAMED06946430419446 EUDAMED06946430418180 EUDAMED06946430417152 EUDAMED06946430417510 EUDAMED06946430418494 EUDAMED06946430419644 EUDAMED06946430417138 EUDAMED06946430425102 EUDAMED06946430417534 EUDAMED06946430418562 EUDAMED06946430422477 EUDAMED06946430423931 EUDAMED06946430418463 EUDAMED06946430417046 EUDAMED06946430422507 EUDAMED06946430417084 EUDAMED06946430418432 EUDAMED06946430419279 EUDAMED06946430417527 EUDAMED06946430417572 EUDAMED06946430421760 EUDAMED06946430417480 EUDAMED06946430422774 EUDAMED06946430417053 EUDAMED06946430423160 EUDAMED06946430423689 EUDAMED06946430422590 EUDAMED06946430418500 EUDAMED06946430418593 EUDAMED06946430417091 EUDAMED06946430422842 EUDAMED06946430417015 EUDAMED06946430422606 EUDAMED06946430418487 EUDAMED06946430419620 EUDAMED06946430418456 EUDAMED06946430417503 EUDAMED06946430418555 EUDAMED06946430417541 EUDAMED06946430419262 EUDAMED06946430418449 EUDAMED06946430417060 EUDAMED06946430418166 EUDAMED06946430418111 EUDAMED06946430422781 EUDAMED06946430422491 EUDAMED06946430422514 EUDAMED06946430418234 EUDAMED06946430422460 EUDAMED06946430418531 EUDAMED06946430422620 EUDAMED06946430422637 EUDAMED06946430422644 EUDAMED06946430426253 EUDAMED06946430425935 EUDAMED06946430410726 EUDAMED06946430425867 EUDAMED
- Basic UDI-DI
- 694643041759217RL EUDAMED694643041759203R9 EUDAMED694643041759218RN EUDAMED694643041759201R5 EUDAMED694643041759204RB EUDAMED694643041336018ND EUDAMED694643041759224RH EUDAMED694643041336009NC EUDAMED694643041336019NF EUDAMED694643041336013N3 EUDAMED694643041759216RJ EUDAMED694643041336016N9 EUDAMED694643041336017NB EUDAMED694643041336010MV EUDAMED694643041759202R7 EUDAMEDB-06946430410726 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMEDSpain EUDAMEDCzechia EUDAMEDPortugal EUDAMEDRomania EUDAMEDPoland 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
PVC Manual Resuscitator by Xiamen Compower Medical Tech. Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, single-use.
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- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 694643041759217RL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 694643041759217RL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (70)
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