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Bailey Retractable Monofilament 10g
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref CH537Model Monofilament
Identity
- Trade Name
- Bailey Retractable Monofilament 10g FDA UDI
- Generic Name
- Point aesthesiometer FDA UDI
- Device Name
- Bailey Retractable Monofilament 10g EUDAMED
- Model / Reference
- CH537 EUDAMEDFDA UDIMonofilament EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060418832285 EUDAMEDFDA UDI
- Basic UDI-DI
- 506041883CH537VH EUDAMED
- Direct Marketing DI
- 05060418832285 EUDAMED
- FDA Product Code
- GXB FDA UDI
- EMDN Code
- H010201010102 POLYAMIDE MONOFILAMENT WITHOUT NEEDLE EUDAMED
- GMDN Term
- Point aesthesiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 882.1500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Point aesthesiometer
Bailey Retractable Monofilament 10g by Bailey Instruments Ltd — 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
- Bailey Instruments Ltd
Sources (2)
- FDA UDI 9b111dea-182a-4097-bdc5-72b3d2679a2d 32 fields · synced Jul 30, 2026
- EUDAMED 04450fd7-dc98-4485-b794-df1a3d782eb8 61 fields · synced Jul 30, 2026