...
This declaration of conformity is issued under the sole responsibility of
| Multiexcerpt include macro |
|---|
| macro_uuid | dd1c8eb6-c5a0-420a-9d94-826518be349f |
|---|
| name | Device classClassification rule |
|---|
| templateData | eJyLjgUAARUAuQ== |
|---|
| page | ME466SUPPPORT-200404 ME |
|---|
| addpanel | false |
|---|
|
.| Multiexcerpt include macro |
|---|
| macro_uuid | dd1c8eb6-c5a0-420a-9d94-826518be349f |
|---|
| name | Classification ruleDevice class |
|---|
| templateData | eJyLjgUAARUAuQ== |
|---|
| page | ME466SUPPPORT-200404 ME |
|---|
| addpanel | false |
|---|
|
| Multiexcerpt include macro |
|---|
| macro_uuid | d51d5ff34a71cc85-6e06802c-4a4b46b4-a56e90b5-93b580521726cbd5b6677b11 |
|---|
| name | Device class_DE |
|---|
| templateData | eJyLjgUAARUAuQ== |
|---|
| page | ME466SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
SRN:
| Multiexcerpt include macro |
|---|
| macro_uuid | e088f24d73220960-ef325872-4dc44ef9-b666b89b-1e1385d708b38e0f72224a8a |
|---|
| name | Manufacturer SRNClassification rule |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | ME466SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
| Multiexcerpt include macro |
|---|
| macro_uuid | dd1c8eb6-c5a0-420a-9d94-826518be349f |
|---|
| name | Manufacturer Official NameDevice class_DE |
|---|
| templateData | eJyLjgUAARUAuQ== |
|---|
| page | ME466SUPPPORT-200404 ME |
|---|
| addpanel | false |
|---|
|
herewith declares that the
| Multiexcerpt include macro |
|---|
| macro_uuid | 87721bae-3691-40e4-ad11-c59f004ce2cc |
|---|
| name | DeviceClassification |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Device and Trade Name (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
consisting in
| Multiexcerpt include macro |
|---|
| macro_uuid | 73f593d5-3d91-46f2-8f14-860be5f89b2a |
|---|
| name | SeptosolDevice class |
|---|
| templateData | eJyLjgUAARUAuQ== |
|---|
| page | Device and Trade Name (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
and
| Multiexcerpt include macro |
|---|
| macro_uuid | 73f593d5-3d91-46f2-8f14-860be5f89b2a |
|---|
| name | NeutrasolDevice class_DE |
|---|
| templateData | eJyLjgUAARUAuQ== |
|---|
| page | Device and Trade Name (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
Basic UDI-DI: | Multiexcerpt include macro |
|---|
| macro_uuid | 95bdebb88ed7d21e-b21e10a2-40a049b5-92c694cf-a6db360e84bcb7f5f4d95a6d |
|---|
| name | Basic UDI-DIDevice class |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Basic UDI-DI (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
EMDN Code:
| Multiexcerpt include macro |
|---|
| macro_uuid | f6374c84-8f69-4177-a530-16ba7f269229 |
|---|
| name | EMDNClassification rule |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Codes (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
to which this certificate refers
...
According to
| Multiexcerpt include macro |
|---|
| macro_uuid | 7b101536-bdb1-4f73-aa6a-d633b9c49d44 |
|---|
| name | Classification rule |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Risk Class and Rule (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
of annex VIII of Council Regulation 2017/745 (201
7) the | Multiexcerpt include macro |
|---|
| macro_uuid | c1231cf2-92a7-4b73-94fa-f383d19ee5bd |
|---|
| name | Device class |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Device and Trade Name (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | false |
|---|
|
is a
| Multiexcerpt include macro |
|---|
| macro_uuid | 07cb6d0f-2349-46a7-ade9-70d0db3082af |
|---|
| name | Device class |
|---|
| templateData | eJyLjgUAARUAuQ== |
|---|
| page | Risk Class and Rule (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
medical device.
The conformity assessment procedure has been performed according to Annex IX.
...
Notified Body involved in the conformity assessment procedure:
| multiexcerpt-include-macro |
|---|
| macro_uuid | 5c4ea813-3971-4414-9bb5-ed853bbc117a |
|---|
| name | CE Notified body nameDevice class |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Notified Body and Certificate Information (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
, Notified Body number:
| Multiexcerpt include macro |
|---|
| name | CE Notified body numbermacro_uuid | a0d8b7d4-a277-489a-882d-3b929ec741d8 |
|---|
| name | Device class |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Notified Body and Certificate Information (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | false |
|---|
|
| multiexcerpt-include-macro |
|---|
| macro_uuid | 27e2cfcb-fadc-4d20-8f2a-e7c08f2567f6 |
|---|
| name | CE Notified body addressClassification rule |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Notified Body and Certificate Information (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
Identification of the certificate or certificates issued:
| Multiexcerpt include macro |
|---|
| macro_uuid | 92493b36-a01c-4904-917f-d55cb27f02fb |
|---|
| name | CE CertificateDevice class |
|---|
| templateData | []eJyLjgUAARUAuQ== |
|---|
| page | Notified Body and Certificate Information (OPT-PER)SUPPPORT-200404 ME |
|---|
| addpanel | falsetrue |
|---|
|
Validity: This declaration of conformity ceases to be valid with the issue of a new declaration of conformity or withdrawal, as well as with the expiry of the certificates issued by the notified body.
...
