Hak
by ChM spółka z ograniczoną odpowiedzialnością 432 variants
Ref 30.1377.000Model RETRACTOR
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The Hak device is a Class I retractor instrument designed for surgical procedures, providing precise control and flexibility. Developed in accordance with international standards, this medical device meets the highest regulatory requirements and ensures patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number59084472NL111M5 05908447029521 | Date14 Aug 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Hak
- Model / reference
- RETRACTOR, 30.1377.000
- Primary DI / UDI-DI
- 05908447029521
- Basic UDI-DI
- 59084472NL111M5
- EMDN code
- L03140199 Spreaders and retractors for general surgery, reusable - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000002121
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Properties
Other properties (12)
- Supplied sterile: No
- Implantable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No