RECTAL SPECULA (Sims, Mathieu, Kelly, Nauton-Morgan)
Ref 53-100 – 53-150Model 39-100 – 39-130
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G26839100391309S ++G26853100531506U | Date11 Sep 2026 | 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- Withdrawn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
- ENT AURICULAR SPECULA (Hartman, Toynbee, Gruber, Siegle)
- Model / Reference
- 39-100 – 39-130, 53-100 – 53-150
- Primary DI / UDI-DI
- ++G26853100531506U
- Basic UDI-DI
- ++G26839100391309S
- EMDN Code
- L040902 Rectal and anal spreaders, reusable
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- PK-MF-000032781
- Authorised representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Other devices from Raydent Instruments
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No