Ref.

Ares(2016)6057338 - 21/10/2016

EC Certificate of Conformity
A.
TÜVRhemland

EC Directive 93/42/EEC Annex VI

Product Quality Assurance
Medical Devices

Registration No.: ED 60110945 0001

Report No.: 28108863 001

Manufacturer: SWORD Health S.A.

Registered Headquarter:
SWORD Health S.A.
Rua Sá da Bandeira, n° 651,1° Direito
4000 - 437 Porto - Portugal

Operational Headquarter: SWORD Health S.A.

Rua Sá da Bandeira, n° 651,1° Direito
4000 - 437 Porto - Portugal

Scope: Rehabilitation device

(See the attachment for typologies, models and codes designation)

Date of Expiry: 18/05/2021

The Notified Body hereby declares that the requirements of annex VI of the Directive 93/42/EEC have been
met for the listed products. The above named manufacturer has established and applies a quality assurance
system, which is subject to periodic surveillance, defined by Annex VI, section 4 of the aforementioned
Directive and can be used in conjunction with the conformity declaration issued by the Manufacturer.

Pogliano Milanese (MI) 19/05/2016

TÜV Rheinland Italia S.r.l. - Via Mattéi, 3 - 20010 - Pogliano Milanese (Ml)
Accreditated by Ministero della Salute and by Ministero dello Sviluppo Economico

Notified under No. 1936 to the EC Commission

The CE marking may be used if all relevant and effective EC Directives are complied with

10/020 h 1М.СИ TÜV. KIEV a^d TUVare registered rfci- UtiRSHtian end application requires prior ßpprovd.
 TÜV Rheinland Italia S.r.l.

Via Mattéi, 3 - 20010 - Pogliano Milanese (Ml)

Ä.
TÜVRheinland
~~

Attachment to the
certificate: ED 60110945 0001

Report No.: 28108863 001

Manufacturer: SWORD Health S.A.

Registered Headquarter-
SWORD Health S.A.
Rua Sá da Bandeira, n° 651,1° Direito
4000 - 437 Porto - Portugal

Operational Headquarter: SWORD Health S.A.

Rua Sá da Bandeira, n° 651,1° Direito
4000 - 437 Porto - Portugal

Scope: Device for the measurement of movement of body parts

Model: SWORD Phoenix

Pogliano Milanese 19/05/2016

TÜV. TUEV antf TUV ага ги и iatereti trademarks. Utilisation and application requires prior approval.