Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Vaginal speculum, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDKRISTELLER VAGINAL SPECULA COMPLETE FIG. 3, SET OF SPECULA AND RETRACTOR LONG MODEL FDA UDI
- Model / Reference
- GU.1202.03 EUDAMEDFDA UDI
- Description
- KRISTELLER VAGINAL SPECULA COMPLETE FIG. 3, SET OF SPECULA AND RETRACTOR LONG MODEL FDA UDI
Identifiers
- Catalog Number
- GU.1202.03 FDA UDI
- Primary DI / UDI-DI
- 04049047045984 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LBR03ANA27DROR6 EUDAMED
- Direct Marketing DI
- 04049047045984 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vaginal speculum, reusable
Gimmi by Gimmi GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI 82da4745-2dce-476f-9d69-f43ef7a3e2eb 35 fields · synced Sep 18, 2026
- EUDAMED 6ffb81a8-9d86-4c8c-8dd5-87074dde5b2d 61 fields · synced Sep 18, 2026