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EUDAMED
1,084
FDA 510(k) incl. De Novo
12
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688
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1,074
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700
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474
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32
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29
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24
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8
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4
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2
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1
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534
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245
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629
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7
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330
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2
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IVD Annex II List A
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IVD for self-testing
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Class
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Disposable Nerve Block Puncture Needles
Suzhou Leapmed Healthcare Corporation
·
,
China
CE/MDR
EPT 0477.MDR.26/6115
Active
Valid to Mar 2031
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Iberian care SAFETY NEEDLES
Zhejiang Kindly Medical Devices Co., Ltd.
·
,
China
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Seratom®
SERAG-WIESSNER GmbH & Co. KG
·
,
Germany
Group of variants
CE/MDD
Active
Regimes:
CE MDD
Registry:
EUDAMED
Class
Class:
IIb
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