Identity
- Trade Name
- KleenSpec EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- KleenSpec 800 Cordless Illuminator FDA UDI
- Model / Reference
- 901070 EUDAMEDFDA UDI80000 EUDAMED
- Description
- KleenSpec 800 Cordless Illuminator FDA UDI
Identifiers
- Catalog Number
- 80000 FDA UDI
- Primary DI / UDI-DI
- 00732094236033 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901070F3 EUDAMED
- FDA Product Code
- HIB FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
KleenSpec by Welch Allyn, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K941272 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0732094GMN901070F3 | Class I | Active |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
- EUDAMED SRN
- US-MF-000013394
- Authorised Representative
- Welch Allyn Limited IE-AR-000000768
Sources (3)
- EUDAMED b60b66b7-cdd9-4690-9ee0-b687529323ed 61 fields · synced Jul 15, 2026
- FDA UDI 19e4b0e2-611b-416b-b514-3016fbbff1eb 35 fields · synced May 30, 2026
- FDA 510(k) K941272 1 fields · synced May 18, 2026