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Cottle Nasal Specula
EUDAMEDClass I (EU MDR)
Ref 42-1070-35Ref 65-0261-75Ref 65-0130-00
Identity
- Device Name
- Cottle Nasal Specula EUDAMED
- Model / Reference
- 42-1070-35 EUDAMED65-0261-75 EUDAMED65-0130-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+D106421070350/* EUDAMED*+D1066502617507* EUDAMED*+D106650130000X* EUDAMED
- Basic UDI-DI
- ++D106SPETULASBE EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMEDL140206 NASAL AND PARANASAL CAVITY SURGERY CANNULAS, REUSABLE EUDAMEDL031402 GENERAL SURGERY SPATULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cottle Nasal Specula by ABI Enterprises — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D106SPETULASBE | Class I | Active |
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Manufacturer
- Manufacturer
- ABI Enterprises
- EUDAMED SRN
- PK-MF-000035328
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED d94af286-ba74-4712-ab77-3c3297410f48 61 fields · synced Jul 22, 2026
- EUDAMED 37aa6f6a-8c9f-427e-8660-a9831768013e 61 fields · synced May 17, 2026
- EUDAMED b5969e86-ba95-4117-9361-5f0d024503d2 61 fields · synced May 19, 2026