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Cusco Specula Insulated with Smoke Tube Broad
EUDAMEDFDA UDIClass I (EU MDR)
Ref CSI100BModel Gynaecological Instruments
Identity
- Trade Name
- Cusco Specula Insulated with Smoke Tube Broad EUDAMEDFDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Model / Reference
- Gynaecological Instruments EUDAMEDCSI100B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060411982246 EUDAMEDFDA UDI
- Basic UDI-DI
- 506021205TF29XQ EUDAMED
- FDA Product Code
- HDF FDA UDI
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.4520 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cusco Specula Insulated with Smoke Tube Broad by Dtr Medical Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506021205TF29XQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dtr Medical Ltd
- EUDAMED SRN
- GB-MF-000023112
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 82d2eb8e-bb8b-481c-b03f-367b17648aab 61 fields · synced Jul 22, 2026
- FDA UDI d637623c-030b-4868-b92b-7e90cdf81dd8 32 fields · synced May 30, 2026