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Sterile Single Use Hartmann Ear Specula OD 3.5mm, 38mm
EUDAMEDClass I (EU MDR)
Ref BTOF1111S
Identity
- Trade Name
- Sterile Single Use Hartmann Ear Specula OD 3.5mm, 38mm EUDAMED
- Device Name
- Sterile Single Use Hartmann Ear Specula OD 3.5mm, 38mm EUDAMED
- Model / Reference
- BTOF1111S EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G075BTOF1111S08 EUDAMED
- Basic UDI-DI
- B-+G075BTOF1111S08 EUDAMED
- EMDN Code
- Q030312 ENT SURGERY SPATULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Single Use Hartmann Ear Specula OD 3.5mm, 38mm by Beauty Teck International (Pvt) Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-+G075BTOF1111S08 | 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 fa2f6473-f4ac-458a-b520-2b279ac5824b 61 fields · synced Jun 19, 2026