1. MANUFACTURER INFORMATION
Legal Manufacturer / OEM / OBL Name * :
Street * :
City / Pincode * :
Country * :
Website Address :
2. ADMINISTRATIVE INFORMATION
Notified Body Slected / Interested?
Select
NB 2265-3EC
NB 2797-BSI
NB 1370-BUREAU VERITAS ITALIA
NB 0633-BERLIN CERT GMBH
NB 2409-CERTISO
NB 0318-CNDC
NB 0546-CERTIQUALITY
NB 1912-DARE
NB 0344/NB 0124-DERKA
NB 2460-DNV
NB 0297-DQS
NB 0537/0477-EUROFINS
NB 0459-GMED
NB 0051-IMQ
NB 0373-ISDI
NB 0426-ITALCERT SRL
NB 2862-INTERTEK
NB 0476/1912-KIWA
NB 0483-MDC
NB 0482-MEDCERT
NB 0050-NSAI
NB 0598/1639-SGS
NB 1304-SIQ
NB 2274-TUV NORD POLSKA
NB 0044-TUV NORD GMBH
NB 0197-TUV RHEINLAND
NB 0123-TUV SUD
NB 2696-UDEM
WILL DECIDED LATER
NOT DECIDED. NEED YOUR HELP
Scope of Manufacturer :
Select
Design, Manufacturer and Sale of Device
Manufacturer and Sale of Device
Assembly, Packing, Labelling and Sale of Device
Third-party Manufacturing and Sale of Device
Own Brand Labeler(OBL)
Scope of I3CGLOBAL :
Select
Technical Documentation without Notified Body Coordination
Technical Documentation with Notified Body Coordination
Technical Documentation-NB Pre Submission Review
Documentation experience and Device Knowledge of the person coordinate with Consultants :
Select
Good
Average
Poor
3. MEDICAL DEVICE DESCRIPTION
Type of Device:
Select
Standalone Software
Active Device
Non Active Device
Procedural Pack (Kits)
Reusable Surgical Instruments
Medicinal Device
Measuring Device
Animal Origin Device
Name of the Medical Device :
Intended use of the device
[ ? ]:
Brand Name / Trade Name :
Number of Models [ ? ]:
Select
ONE
TWO
1-5
1-10
1-20
1-40
1-100
1-1000
Class of Device as per MDR :
Select
Class 1
Class 1 Sterile
Class 1 Measuring
Class 1 Reusable
Class 11 a
Class 11 b
Class 111
Device Body Contact :
Select
External Body Contact
No Body Contact
Limited (< 24h)
Prolonged (24h to 30 days)
Long Term (> 30 days)
Device Invasive action by :
Select
Not Applicable
With the help of surgical procedure
Body orifice
Totally introduced into the body through surgical procedure
Partially introduced into the body through surgical procedure
Medical Device functions on :
Select
Self Operation
Self Operation with the help of App
Home Healthcare
Clinical Use
Home and Clinical use
Clinical use with the Aid of Software
Combination with other medical device
Non of the above
Is the device used in :
Select
Central circulatory system
Central nervous system
Non of the above
Medical Device packed :
Select
Sterile
Non Sterile
Any accessories / consumables packed along with the device:
Select
No
Yes, Accessories and consumables included in the final pack
Yes, Accessories included in the final pack
Yes, consumables included in the final pack
Name the accessories and consumables:
4. SUBMITTER INFORMATION
Contact Person * :
Mr
Mrs
Dr
Prof
Ms
Job Title * :
Contact Number * :
Contact Email * :