Procept BioRobotics
by Microtek Medical LLC EUDAMED
Active
Ref DR4000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0748426MP01PL35INZ0CK | Date28 Sep 2026 | 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- Withdrawn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
- Device Name
- Procedural Drape Kits
- Model / Reference
- DR4000
- Primary DI / UDI-DI
- 00748426262069
- Basic UDI-DI
- 0748426MP01PL35INZ0CK
- EMDN Code
- T0202 Surgical procedural kits (excluding surgical instrument kits)
- Device Class
- Class I
- Medical Purpose
- The Essential Drape Pack is intended to provide coverings for the patient and equipment in surgical urological procedures. Parker Eclipse Probe Covers are intended to be used as a physical barrier for protection against the effects of environmental exposure and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination. This is a single-use device.
Manufacturer details
- EUDAMED SRN
- US-PR-000022773
Other devices from Microtek Medical LLC
Properties
Other properties (1)
- Sterile: No