Identity
- Trade Name
- Sterile equipment drape FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Sterile Drapes for technical medical devices and microscopes EUDAMEDfor Zeiss / Möller-Wedel microscopes HQ lens, Ø 65 mm,10 pieces / box FDA UDI
- Model / Reference
- 2565080H EUDAMEDFDA UDI
- Description
- for Zeiss / Möller-Wedel microscopes HQ lens, Ø 65 mm,10 pieces / box FDA UDI
Identifiers
- Catalog Number
- 2565080H FDA UDI
- Primary DI / UDI-DI
- 04250381811283 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250381811283 EUDAMED
- FDA Product Code
- PUI FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Medical equipment/instrument drape, single-use
Sterile equipment drape by Spiggle & Theis Medizintechnik GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spiggle & Theis Medizintechnik GmbH
Sources (2)
- FDA UDI 443b3b82-c9fd-4793-807d-ef8bd28190d5 35 fields · synced Oct 10, 2026
- EUDAMED f9d79191-a5d5-41f3-9092-29d737a0a38a 61 fields · synced Oct 10, 2026