European Radio Equipment Directive (2014/53/EU)
Declarations of Conformity
"All Documents" (-)
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ALTRUA™ 2 | ESSENTIO™ | ESSENTIO™ MRI | PROPONENT™ | PROPONENT™ MRI | ACCOLADE™ | ACCOLADE™ MRI | VALITUDE™ | VISIONIST™ Declaration of Conformity
PDF( 439.0 KB )
Models:
ALTRUA 2 (S701, S702, S722)
ESSENTIO (L100, L101, L121)
ESSENTIO MRI (L110, L111, L131)
PROPONENT (L200, L201, L221, L209)
PROPONENT MRI (L210, L211, L231)
ACCOLADE (L300, L301, L321)
ACCOLADE MRI (L310, L311, L331)
VALITUDE (U125, U128)
VISIONIST (U225, U226, U228) -
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AUTOGEN™ | DYNAGEN™ | INOGEN™ | ORIGEN™ | RESONATE™ | RESONATE™ HF | CHARISMA™ | VIGILANT™ | PERCIVA™ | PERCIVA™ HF | MOMENTUM™ Declaration of Conformity
PDF( 259.0 KB )
Models:
AUTOGEN (D046, D044, D047, D045, D176, D174, D177, D175, G179, G172, G177, G173, G175)
DYNAGEN (D022, D020, D023, D021, D152, D150, D153, D151, G158, G150, G156, G151)
INOGEN (D012, D010, D013, D011, D142, D140, D143, D141, G148, G140, G146, G141)
ORIGEN (D002, D000, D003, D001, D052, D050, D053, D051, G058, G050, G056, G051)
RESONATE (D420, D421, D432, D433, G424, G425, G426, G428, G437, G447, G448)
RESONATE HF (D520, D521, D532, D533, G524, G525, G526, G528, G537, G547, G548)
CHARISMA (D320, D321, D332, D333, G324, G325, G328, G337, G347, G348)
VIGILANT (D220, D221, D232, D233, G224, G225, G228, G237, G247, G248)
PERCIVA (D400, D401, D412, D413)
PERCIVA HF (D500, D501, D512, D513)
MOMENTUM (D120, D121, G124, G125, G126, G128, G138) -
AVVIGO Guidance System 2.0 Declaration of Conformity
PDF( 519.0 KB )
Model: AVVIGO Guidance System 2.0 FFR Link
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AVVIGO Guidance System Declaration of Conformity
PDF( 434.0 KB )
Model: AVVIGO Guidance System Tablet
FFR Link -
Clinician Programmer (Microsoft Surface Pro 6) Declaration of Conformity
PDF( 1.0 MB )
Model: Microsoft Surface Pro 6
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Clinician Programmer (Microsoft Surface Pro 6) Power Supply RED Declaration of Conformity
PDF( 450.0 KB )
Model: Microsoft Surface Pro 6
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FFR Link and Bluetooth Communication Module
PDF( 751.0 KB )
Models:
FFR Link
Bluetooth Communication Module
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Lumenis GmbH Pulse 120H RED Declaration of Conformity
PDF( 614.0 KB )
Model: Lumenis GmbH Pulse 120H
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Lumenis GmbH Pulse 30 | Lumenis GmbH Pulse 60 | Lumenis GmbH Pulse 50 | Lumenis GmbH Pulse 100 | AcuPulse GmbH Duo | UltraPulse GmbH Duo Declaration of Conformity
PDF( 629.0 KB )
Lumenis GmbH Pulse 30 | Lumenis GmbH Pulse 60 | Lumenis GmbH Pulse 50 | Lumenis GmbH Pulse 100 | AcuPulse GmbH Duo | UltraPulse GmbH Duo
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Lumenis Ltd Pulse 30 | Lumenis Ltd Pulse 60 | Lumenis Ltd Pulse 50 | Lumenis Ltd Pulse 100 | AcuPulse Ltd Duo | UltraPulse Ltd Duo Declaration of Conformity
PDF( 13.0 MB )
Lumenis Ltd Pulse 30 | Lumenis Ltd Pulse 60 | Lumenis Ltd Pulse 50 | Lumenis Ltd Pulse 100 | AcuPulse Ltd Duo | UltraPulse Ltd Duo
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PRECISION™ SPINAL CORD STIMULATOR SYSTEM | PRECISION SPECTRA™ SPINAL CORD STIMULATOR SYSTEM | PRECISION NOVI™ SPINAL CORD STIMULATOR SYSTEM | PRECISION™ MONTAGE™ MRI SPINAL CORD STIMULATOR SYSTEM| PRECISION™ MONTAGE™ SPINAL CORD STIMULATOR SYSTEM | SPECTRA WAVEWRITER™ SPINAL CORD STIMULATOR SYSTEM Declaration of Conformity
PDF( 7.0 MB )
Models: PRECISION SYSTEM (SC-1110-02, SC-1112, SC-5110, SC-5112, SC-5212, SC-5213, SC-5500-4, SC-5312, SC-6412-3) PRECISION SPECTRA SYSTEM (SC-1132, SC-5132, NM-7190, SC-5232, SC-5532-1, SC-5532-1A, SC-5312, SC-6412-3) PRECISION NOVI SYSTEM (SC-1140, SC-5132, NM-7190, SC-5240, SC-5542-1A, SC-1042-A) PRECISION MONTAGE AND PRECISION MONTAGE MRI SYSTEMS (SC-1120, SC-1200, SC-5132, NM-7190, SC-5250, SC-5552-1A, SC-5312, SC-6412-3, SC-1210B) SPECTRA WAVEWRITER SYSTEM (SC-1160, SC-5160, SC-5160R, SC-5260, SC-5562-1A, NM-7190, SC-5312, SC-6412-3)
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Rhythmia HDx™ Mapping System Declaration of Conformity
PDF( 407.0 KB )
Model: Rhythmia HDx™ Mapping System
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Vercise Genus™ DBS System and WaveWriter Alpha™ System Declaration of Conformity
PDF( 2.0 MB )
Models: DB-1408, DB-1416, DB-1432, DB-1216, DB-1232, DB-5170, DB-5270, DB-5572-1A, SC-1216, SC-1232, SC-1416, SC-1432, SC-5170, SC-5170R, SC-12010, SC-12030, SC-14016, SC-14032, SC-5270, SC-5270R, SC-5572-1A
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VERCISE™ DEEP BRAIN STIMULATION SYSTEM | VERCISE™ PC DEEP BRAIN STIMULATION SYSTEM | VERCISE GEVIA™ DEEP BRAIN STIMULATION SYSTEM Declaration of Conformity
PDF( 9.0 MB )
Models:
VERCISE SYSTEM (DB-1110-C, DB-5110-C, DB-5212-C, DB-5500-C, NM-5312, DB-6412-EU-C, SC-6412-3)
VERCISE PC SYSTEM (DB-1140, DB-5132, NM-7190, DB-5240, DB-5542-1A)
VERCISE GEVIA SYSTEM (DB-1200, DB-5132, DB-7190, NM-7190, DB-5250, DB-5552-1A, NM-5312, DB-6412-5, DB-6412-EU-C, SC-5312, SC-6412-3)