Apatech Limited

• DE/CA304 - Marktüberwachung Medizinprodukte Bayern
  GermanyContact the authority →

Devices placed in 25 countries

• Austria1
• Belgium1
• Bulgaria1
• Cyprus1
• Czechia1
• Germany1
• Denmark1
• Spain1
• Finland1
• France1
• Greece1
• Croatia1
• Ireland1
• Italy1
• Liechtenstein1
• Lithuania1
• Luxembourg1
• Malta1
• Netherlands1
• Norway1
• Poland1
• Portugal1
• Romania1
• Sweden1
• XI1

6 contacts identified

• JD
  PRRC
• MP
  PRRC
• ON
  PRRC
• MASON Paul
  (1) Ensure conformity of the device is appropriately checked in accordance with the QMS before the device is released; (2) Ensure technical documentation and EU Declaration of Conformity are approved; (3) Ensure PMS obligations are met; (4) Ensure reporting obligations relating to vigilance are met
  Hidden
• JOHNSON Daniel
  (1) Ensure technical documentation and EU Declaration of Conformity are prepared; (2) Ensure that the Declaration for investigational device(s) used in clinical trials conforms to General Safety and Performance Requirements (GSPR) apart from aspects covered by the clinical investigation and every precaution has been taken to protect the health and safety of the subject
  Hidden
• OMER-JIN Nadeem
  (1) Ensure technical documentation and EU Declaration of Conformity are prepared
  Hidden

• BSI Group The Netherlands B.V. — 1 certificate — Apatec
• Baxter Deutschland GmbH — represents — Apatec
• JOHNSON Daniel — Apatec
• MASON Paul — Apatec
• OMER-JIN Nadeem — Apatec