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Non-Sterile Single Use Hartmann Ear Specula Adult Aural. Inside Non-Reflective/…
EUDAMEDClass I (EU MDR)
Ref BTOF1355
Identity
- Trade Name
- Non-Sterile Single Use Hartmann Ear Specula Adult Aural. Inside Non-Reflective/Outside Mirror Finish -OD 2.0mm EUDAMED
- Device Name
- Non-Sterile Single Use Hartmann Ear Specula Adult Aural. Inside Non-Reflective/Outside Mirror Finish -OD 2.0mm EUDAMED
- Model / Reference
- BTOF1355 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G075BTOF13550X EUDAMED
- Basic UDI-DI
- B-+G075BTOF13550X EUDAMED
- EMDN Code
- Q030312 ENT SURGERY SPATULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Non-Sterile Single Use Hartmann Ear Specula Adult Aural. Inside Non-Reflective/… by Beauty Teck International (Pvt) Ltd — Class I — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+G075BTOF13550X | Class I | Active |
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Manufacturer
- Manufacturer
- Beauty Teck International (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000009604
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED cd5aeff0-4c4c-4f4d-b7e4-e326e365c2a9 61 fields · synced Oct 7, 2026