Profimed
by Θ.καζαντζιδης Αε - Medipac 124 variants
Part of a family of 124 devices: see the family page
Ref PR210D
Profimed (PR210D) is a Class III device made by Θ.καζαντζιδης Αε - Medipac, registered in EUDAMED on 24 May 2024 (Basic UDI-DI B-05206913006459) with CE/MDR certificate C07 GR027637 2412 valid until 19 Dec 2029, active as of 26 Oct 2026.
Active
CE MDR CE MDD
Valid until
19 Dec 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberC07 GR027637 2412 | Date16 Mar 2026 | StatusActive |
| European Union | CE/MDD | NumberB-05206913006459 05206913006459 | Date24 May 2024 | StatusActive |
Official records
- EUDAMED public site B-05206913006459
Certificates
- C07 GR027637 2412 Active
Technical documentation EU MDR
- Certifier
- HTCert (Health Technology Certification Ltd) 2803
- Issued
- 16 Mar 2026
- Expires
- 19 Dec 2029
Timeline
- Registered EUDAMED B-05206913006459
- Certificate issued EUDAMED C07 GR027637 2412
- Certificate expires EUDAMED C07 GR027637 2412
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Model / reference
- PR210D
- Primary DI / UDI-DI
- 05206913006459
- Basic UDI-DI
- B-05206913006459, 5206913PROFIMED8Q
- EMDN code
- H010201010501 Polytetrafluoroethylene (ptfe) monofilament with needle
- Device class
- Class III
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- GR-MF-000027637
Similar devices in this category
Other devices filed under POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE.
- Biotex BT3019 by PURGO BIOLOGICS Inc.
- GORE-TEX Suture 6K08 by W. L. Gore & Associates, Inc.
- GORE-TEX Suture 0U06 by W. L. Gore & Associates, Inc.
- Cytoplast™ PTFE Suture CS0628RC by OSTEOGENICS BIOMEDICAL, INC.
- Biotex BT5013 by PURGO BIOLOGICS Inc.
- Cytoplast™ PTFE Suture CS0618PREM by OSTEOGENICS BIOMEDICAL, INC.
- Demetech PTFE TE655016F4P by DemeTECH Corp
- Demetech PTFE TE154016F13M by DemeTECH Corp
- OSSEOGUARD® OS2019 by ZimVie US Corp LLC
- OSSEOGUARD® OS4013PE by ZimVie US Corp LLC