Identity
- Trade Name
- Kristeller Speculum EUDAMED
- Device Name
- FOREIGN BODY MATHIEU FORCEPS, 265MM EUDAMED
- Model / Reference
- G2136 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89640048542628 EUDAMED
- Basic UDI-DI
- 8964004854gynecologyJ3 EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Category: Vaginal speculum, reusable
Kristeller Speculum by Gynemed — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal speculum, reusable.
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Doyen hüvelylapoc, enyhén ívelt, 90x60 mm, 240 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Non-Digital Vaginal Examination Duckbill Large Stainless Steel — Nadeem Surgical Corporation (Pvt.) Ltd. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- ELMED — ELMED INCORPORATED · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
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 | 8964004854gynecologyJ3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gynemed
- EUDAMED SRN
- PK-MF-000042135
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 8c5287f0-e0f1-491b-acfb-bae2bf863fc3 61 fields · synced Jul 24, 2026