EC DECLARATION OF CONFORMITY
PH I L I PS
Philips Medical Systems 3000 Minuteman Rd.
Andover, MA 0181 0-1 099 U.S.A.
This declaration of conformity is issued under the sole responsibility of the manufacturer.
Product Name: See Schedule 1
Product Model Number or Designator: See Schedule 1
Control Indicator: All products shipped on or after August 29, 2016
Device Classification per specified directive: Class Ha, Rule X, perAnnex IX of Directive 93/42/EEC Global Medical Device Nomenclature Code (GMDN) and Title: 35254 Electronic thermometer probe, single-use
Product OptionslAccessories: N/A
The object of the declaration described above is in conformity with:
Council Directive: 93/42/EEC, Annex II- Section 3.2 concerning medical devices as amended by 2007/471EC
EC Certificate information:
The Manufacturer is certified by the Notified Body listed below to EN 13485 and Annex II excluding (4) of the Medical Device Directive 93/42/EEC. Copies of the certificates are available upon request
NamelAddress/ldentification Numbers of Notified Body:TUV SÜD Product Service GmbH, Zertifizierstelle, Ridlerstrasse 65, 80339 Munchen, Germany, 0123
NamelAddress or Authorized EU Representative: Philips Medizin Systeme Böblingen GmbH, Hewlett- Packard Str. 2, 71034 Böblingen, Germany
Additional Information:
The products listed above have been tested in a typical configuration as described in the Manufacturer’s accompanying documentation. The products are fully compliant with the relevant harmonized standards.
Additionally the products listed above have been designed, manufactured, tested, and found to be
compatible with the devices and accessories described by the manufacturer in the devices accompanying documentation.
Date of Issue: 29Aug2016
Printed Name: Christine Trefethen Place of Issue: Andover
Title: Regulatory Affairs Manager, MCS
Document Identification No.: AW-5954-4614-2 Revision No.:H Page 1 of 2
EC DECLARATION OF CONFORMITY
Schedule 1:
Part Model Number Description
21091A Skin Temperature Probe
21090A Esophageal/Rectal Temperature Probe 12FR Ml 83 7A Esophageal/Rectal Temperature Probe 9FR 21093A Esophageal/Stethoscope Temperature Probe 12FR 21 094A Esophageal Stethoscope Temperature Probe 1 8FR 21095A Esophageal Stethoscope Temperature Probe 24FR
Document Identification No.: AW-5954-4614-2 Revision No.:H Page: 2 of 2
