Identity
- Trade Name
- Pelvic Floor Exerciser EUDAMED
- Device Name
- Pelvic Floor Exerciser EUDAMED
- Model / Reference
- PF01 EUDAMEDPF03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927394502733 EUDAMED
- Basic UDI-DI
- 69273945PO05WJ EUDAMED
- Direct Marketing DI
- 06927394502733 EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Pelvic Floor Exerciser by Hunan Accurate Bio-Medical Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252748 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69273945PO05WJ | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Accurate Bio-Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012835
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e97511e4-0694-40f1-b60f-6dbf326bdcf4 61 fields · synced Oct 7, 2026
- FDA 510(k) K252748 1 fields · synced May 18, 2026