CarnaLife Holo
by Medapp Spółka Akcyjna W Restrukturyzacji Poland EUDAMED
Ref 05904978657028 EMDN Z12040292
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberTNP/MDR/0025/4478/2024 | Date25 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- TNP/MDR/0025/4478/2024 Restricted
Quality management system EU MDR
- Notified body
- TUV NORD Polska Sp. z o.o 2274
- Issued
- 25 Jun 2025
- Expires
- 8 Sep 2027
- Reason
- Not on market
Specification
- Model / Reference
- 05904978657028
- Primary DI / UDI-DI
- 05904978657028
- Basic UDI-DI
- 5904978657CLHJV
- EMDN Code
- Z12040292 General medicine therapeutic treatment instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000029453
From the manufacturer
Manufacturer's product page: CarnaLife Holo MedNav
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED c3d8be8d-1a4f-4b85-bcaf-1e578eadae23