Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Vaginal speculum, reusable FDA UDI
- Device Name
- Vaginal speculum EUDAMEDAUVARD SPEC W/DETACH-WEIGHT105X43-40MM FDA UDI
- Model / Reference
- EL739R EUDAMEDFDA UDI
- Description
- AUVARD SPEC W/DETACH-WEIGHT105X43-40MM FDA UDI
Identifiers
- Catalog Number
- EL739R FDA UDI
- Primary DI / UDI-DI
- 04038653153565 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000000440ZU EUDAMED
- Direct Marketing DI
- 04038653153565 EUDAMED
- FDA Product Code
- HDF FDA UDI
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
- GMDN Term
- Vaginal speculum, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.4520 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vaginal speculum, reusable
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4039239000000440ZU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED a3920813-2540-4418-8785-c64a709f0a32 61 fields · synced May 30, 2026
- FDA UDI b364d610-e45d-4aaa-94f0-198fa9b0ae9f 35 fields · synced May 30, 2026