Probe cover kit
by Exact Medical Manufacturing, Inc EUDAMED
Active
Ref P6449, P6418, 1303116, E6341, V2000, E6445, E6329G, E6331, P6413, P6450, E6415, E6428, 1303565, 1304816, E6332G, E6439N, 1304833, E6349G, E6413, E6432N, E6345, E6442, E6448N, E6302N, E6360, P6339G, E6431, E6343, E6347N, E6452, E6328G, E6322N, E6427, E6441, 1302112, E6412, E6359, E6410, P6336G, E6402, P6435A, E6418, E6333, E6407, E6336G, E6440, E6447N, E6417N, 1304631, 63053-01, AM7001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697542419SP05NS | Date25 Aug 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Trade Name
- Probe cover kitProbe Cover
- Device Name
- Microscope DrapeC-Arm kit
- Model / Reference
- P6449, P6418, 1303116, E6341, V2000, E6445, E6329G, E6331, P6413, P6450, E6415, E6428, 1303565, 1304816, E6332G, E6439N, 1304833, E6349G, E6413, E6432N, E6345, E6442, E6448N, E6302N, E6360, P6339G, E6431, E6343, E6347N, E6452, E6328G, E6322N, E6427, E6441, 1302112, E6412, E6359, E6410, P6336G, E6402, P6435A, E6418, E6333, E6407, E6336G, E6440, E6447N, E6417N, 1304631, 63053-01, AM7001
- Primary DI / UDI-DI
- 06975424190573, 06975424190610, 06975085709657, 06975424191044, 06975085709596, 06975424190757, 06975424191129, 06975424191105, 06975424190627, 06975424190566, 06975424190900, 06975424190863, 06975085709671, 06975085709770, 06975424191099, 06975085707622, 06975085709787, 06975424190993, 06975424190917, 06975085708414, 06975424191013, 06975424190771, 06975085708803, 06975424193246, 06975424191150, 06975424190658, 06975424190849, 06975424191037, 06975085708483, 06975424190689, 06975424191136, 06975085707561, 06975424190870, 06975424190788, 06975085709640, 06975424190924, 06975424191143, 06975424190931, 06975424190665, 06975424190962, 06975424190580, 06975424190887, 06975424191082, 06975424190948, 06975424191075, 06975424190795, 06975085708797, 06975085709060, 06975085709695
- Basic UDI-DI
- 697542419SP05NS, 697508570EC07JD, 697508570EC03J5, 697542419SP01NJ
- EMDN Code
- T0202, T030102, T030199
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000001406
- Authorised representative
- Exact Medical Manufacturing B.V. NL-AR-000000452
Other devices from Exact Medical Manufacturing, Inc
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No