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Bioteque Taiwan Ltd.
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref M0014Model Endometrial Sampling Curettes
Identity
- Trade Name
- Preferred Curette EUDAMEDBioteque Taiwan Ltd. FDA UDI
- Generic Name
- Endometrial biopsy kit FDA UDI
- Device Name
- Endometrial Sampling Curettes EUDAMED
- Model / Reference
- M0014 EUDAMEDFDA UDIEndometrial Sampling Curettes EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719894432311 EUDAMEDFDA UDI
- Basic UDI-DI
- 47198944302009M EUDAMED
- 510(k) Number
- K092982 FDA UDI
- FDA Product Code
- HHK FDA UDI
- EMDN Code
- U089010 UTERINE CURETTES, SINGLE-USE EUDAMED
- GMDN Term
- Endometrial biopsy kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1175 FDA UDI
- Market of Registration
- Ireland 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endometrial biopsy kit
Bioteque Taiwan Ltd. by Bioteque Taiwan Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endometrial biopsy kit.
- Gynosampler — Gynetics Medical Products NV · Class II
- Gynex — GYNEX CORPORATION · Class II
- Patel Pipelle — TITUS MEDICAL LLC · Class II
- Echosampler — Gynetics Medical Products NV · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- Suresample, Endometrial Sampler — GYNEX CORPORATION · Class II
- Wallach Endocell — CooperSurgical, Inc. · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bioteque Taiwan Ltd.
Sources (2)
- FDA UDI 6e338e59-248e-4b07-a48b-a9d7f3cac074 33 fields · synced Jul 11, 2026
- EUDAMED 69c95ed0-5b32-4f29-9601-6d0616c813ca 61 fields · synced Jul 11, 2026