Identity
- Trade Name
- DORO® Lubricant HP500, Six-pack EUDAMEDDORO® Lubricant HP500 FDA UDI
- Generic Name
- Surgical instrument maintenance lubricant FDA UDI
- Device Name
- Oil EUDAMEDDORO® Lubricant HP500, Six-pack FDA UDI
- Model / Reference
- 1001.998 EUDAMEDFDA UDI
- Description
- DORO® Lubricant HP500, Six-pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435528129 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA09EZ EUDAMED
- Direct Marketing DI
- 04250435526996 EUDAMED
- FDA Product Code
- FWX FDA UDIJEA FDA UDI
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument maintenance lubricant FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI878.4960 FDA UDI
- Market of Registration
- Germany 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic trocar blade, reusable
DORO® Lubricant HP500, Six-pack by Black Forest Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504355PA09EZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Black Forest Medical GmbH
- EUDAMED SRN
- DE-MF-000005752
Sources (2)
- EUDAMED 1b958db7-a4d7-4ecc-b394-e31e44941e31 61 fields · synced Jun 18, 2026
- FDA UDI cc0b0ca0-bca0-42a2-9e37-8197473317d1 33 fields · synced May 30, 2026