ProPak 02
Ref 07520
ProPak 02 (07520) is a medical device (EU MDR Class I; EMDN category retraction wires and gingival retractors) made by Pascal Company, Inc., registered in EUDAMED on 12 Aug 2026 (Basic UDI-DI 03108662006G8), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number03108662006G8 00310866002804 | Date12 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 03108662006G8
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- ProPak Retraction Cord
- Model / reference
- 07520
- Primary DI / UDI-DI
- 00310866002804
- Basic UDI-DI
- 03108662006G8
- EMDN code
- Q010204 Retraction wires and gingival retractors
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- US-MF-000032036
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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